CP-690,550-10 ( DrugBank: - )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ39
96クローン病30
97潰瘍性大腸炎74
107若年性特発性関節炎24
271強直性脊椎炎6

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002337-30-HR
(EUCTR)
05/06/201712/09/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
2EUCTR2016-002337-30-DE
(EUCTR)
24/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
269 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
3EUCTR2016-002337-30-CZ
(EUCTR)
03/05/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
4EUCTR2016-002337-30-BG
(EUCTR)
11/04/201730/01/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
5EUCTR2016-002337-30-SK
(EUCTR)
10/04/201708/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.,NULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
6EUCTR2016-002337-30-ES
(EUCTR)
27/03/201710/03/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
7EUCTR2016-002337-30-HU
(EUCTR)
16/03/201706/02/2017A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatmentA 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
230Phase 2Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
8EUCTR2013-003177-99-AT
(EUCTR)
17/08/201507/05/2015A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
9EUCTR2013-003177-99-FI
(EUCTR)
12/08/201512/02/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc., 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
10EUCTR2014-000358-13-PL
(EUCTR)
03/12/201424/09/2014A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisA PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A Moderately to severely active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate sodium 2.5mg tablets
Product Name: Methotrexate sodium 2.5mg tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
1080Phase 3;Phase 4Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
11EUCTR2011-005689-39-SK
(EUCTR)
24/09/201407/07/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
12EUCTR2013-003177-99-NL
(EUCTR)
09/09/201425/02/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
13EUCTR2011-005689-39-NL
(EUCTR)
01/09/201423/06/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Spain;Poland;Russian Federation;Germany;Netherlands;Korea, Republic of
14EUCTR2013-003177-99-GB
(EUCTR)
17/07/201411/03/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
15EUCTR2013-003177-99-CZ
(EUCTR)
10/07/201405/02/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4Mexico;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
16EUCTR2013-003177-99-ES
(EUCTR)
07/05/201417/03/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
17EUCTR2013-003177-99-SK
(EUCTR)
28/04/201410/03/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
18EUCTR2013-003177-99-SE
(EUCTR)
11/04/201405/02/2014A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 3;Phase 4United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
19EUCTR2011-005689-39-DE
(EUCTR)
20/01/201424/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
20EUCTR2011-005689-39-CZ
(EUCTR)
07/08/201323/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
21EUCTR2011-005689-39-HU
(EUCTR)
27/06/201322/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
22EUCTR2011-005689-39-ES
(EUCTR)
26/06/201324/06/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
23EUCTR2007-002066-35-SK
(EUCTR)
10/10/201215/04/2008A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
24EUCTR2006-005035-19-IE
(EUCTR)
06/01/201007/10/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
25EUCTR2006-005035-19-FI
(EUCTR)
21/09/200915/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
26EUCTR2006-005035-19-GB
(EUCTR)
03/09/200927/04/2009 A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
4500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
27EUCTR2006-005035-19-DK
(EUCTR)
11/08/200923/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate( Phase III formulation)
Product Code: CP-690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation debossed)
Product Code: CP-690,550-10
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
28EUCTR2006-005035-19-BG
(EUCTR)
04/08/200810/06/2009A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: Tofacitinib citrate (Proposed commercial formulation- debossed)
Product Code: CP-690,550-10
INN or Proposed INN: NA
Other descriptive name: NA
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
29EUCTR2007-002066-35-HU
(EUCTR)
28/03/200823/07/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
30EUCTR2007-002066-35-GR
(EUCTR)
11/02/200820/09/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
31EUCTR2007-002066-35-DE
(EUCTR)
01/02/200817/02/2009A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg Injektionslösung in Fertigspritze
INN or Proposed INN: Adalimumab
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Czech Republic;Germany;Bulgaria;Italy;Greece
32EUCTR2006-005035-19-DE
(EUCTR)
01/02/200804/10/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
33EUCTR2007-002066-35-BG
(EUCTR)
31/01/200815/02/2008A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Czech Republic;Hungary;Greece;Bulgaria;Germany;Italy
34EUCTR2007-002066-35-CZ
(EUCTR)
09/01/200823/10/2007A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Product Name: CP-690,550
Other descriptive name: CP-690,550-10
Trade Name: Humira® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira®
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
35EUCTR2006-005035-19-CZ
(EUCTR)
14/11/200720/09/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citate (Phase III formulation)
Product Code: CP-690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
36EUCTR2006-005035-19-SK
(EUCTR)
10/07/200709/04/2008A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550
Product Code: CP-690,550-10
Product Name: CP-690,550
Product Code: CP-690,550-10
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
37EUCTR2006-005035-19-SE
(EUCTR)
04/05/200716/03/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
38EUCTR2006-005035-19-BE
(EUCTR)
17/04/200709/01/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4500Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
39EUCTR2006-005035-19-AT
(EUCTR)
15/02/200712/02/2007A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
4000Phase 2;Phase 3United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-003622-27-NL
(EUCTR)
30/10/201319/02/2013A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
2EUCTR2011-001754-28-HR
(EUCTR)
22/08/201328/08/2014A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Czech Republic;Hungary;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
3EUCTR2011-003622-27-HR
(EUCTR)
20/08/201328/08/2014A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
4EUCTR2011-001733-16-HR
(EUCTR)
19/08/201328/08/2014A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
5EUCTR2011-003622-27-AT
(EUCTR)
04/06/201318/03/2013A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
6EUCTR2011-001754-28-NL
(EUCTR)
15/11/201227/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
7EUCTR2011-001733-16-NL
(EUCTR)
15/11/201222/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
8EUCTR2011-001754-28-CZ
(EUCTR)
12/11/201215/02/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
9EUCTR2011-001733-16-CZ
(EUCTR)
12/11/201222/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
10EUCTR2011-003622-27-CZ
(EUCTR)
12/11/201203/04/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
11EUCTR2011-003622-27-DE
(EUCTR)
20/08/201230/03/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE - Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Netherlands Antilles;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
12EUCTR2011-003622-27-BG
(EUCTR)
11/07/201219/05/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of
13EUCTR2011-003622-27-SE
(EUCTR)
07/06/201209/02/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
14EUCTR2011-003622-27-GR
(EUCTR)
05/06/201224/05/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
15EUCTR2011-001754-28-DE
(EUCTR)
05/06/201217/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
16EUCTR2011-001733-16-BG
(EUCTR)
29/05/201230/03/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of
17EUCTR2011-001754-28-BG
(EUCTR)
29/05/201207/05/2012A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
18EUCTR2011-003622-27-HU
(EUCTR)
10/05/201221/03/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Ukraine;United States;Greece;Spain;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
19EUCTR2011-003622-27-ES
(EUCTR)
17/04/201216/02/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASE Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
20EUCTR2011-001733-16-DE
(EUCTR)
10/04/201218/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
21EUCTR2011-001754-28-GR
(EUCTR)
02/04/201216/02/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
22EUCTR2011-001754-28-ES
(EUCTR)
02/02/201207/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn?s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
23EUCTR2011-001754-28-AT
(EUCTR)
26/01/201221/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
24EUCTR2011-001733-16-AT
(EUCTR)
26/01/201221/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
25EUCTR2011-001733-16-HU
(EUCTR)
24/01/201214/11/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Norway;Germany;Japan;Korea, Republic of;Sweden
26EUCTR2011-001754-28-HU
(EUCTR)
10/01/201217/11/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
27EUCTR2011-001733-16-GR
(EUCTR)
09/01/201214/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
28EUCTR2011-001733-16-ES
(EUCTR)
23/12/201128/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn?s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
29EUCTR2011-001754-28-SE
(EUCTR)
14/12/201119/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Australia;South Africa;Croatia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
30EUCTR2011-001733-16-SE
(EUCTR)
17/11/201119/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002378-30-DE
(EUCTR)
14/04/202213/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
2EUCTR2018-002378-30-HU
(EUCTR)
01/03/202215/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
3EUCTR2018-002378-30-FI
(EUCTR)
22/12/202120/12/2021OPEN-LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan;Sweden
4EUCTR2017-002274-39-NL
(EUCTR)
27/06/201819/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
5EUCTR2017-002274-39-GB
(EUCTR)
12/04/201820/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesSerbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
6EUCTR2017-002274-39-BE
(EUCTR)
22/02/201818/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
7EUCTR2017-002274-39-IT
(EUCTR)
20/02/201812/02/2021A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLELGROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION - NA Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
PFIZER INCNULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
8EUCTR2017-002274-39-CZ
(EUCTR)
16/01/201814/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
9EUCTR2017-002274-39-AT
(EUCTR)
04/01/201820/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
10EUCTR2017-002274-39-ES
(EUCTR)
21/12/201722/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
11EUCTR2017-002274-39-HU
(EUCTR)
21/12/201719/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
12EUCTR2017-002274-39-SK
(EUCTR)
08/12/201727/10/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: CP-690,550
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
130Phase 3;Phase 4United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
13EUCTR2011-004579-35-HR
(EUCTR)
27/08/201328/08/2014A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
14EUCTR2011-004581-14-HR
(EUCTR)
26/08/201328/08/2014A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
725Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
15EUCTR2011-004580-79-HR
(EUCTR)
26/08/201328/08/2014A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
16EUCTR2011-004578-27-HR
(EUCTR)
26/08/201328/08/2014A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
17EUCTR2011-004578-27-NL
(EUCTR)
04/03/201312/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada
18EUCTR2011-004580-79-IT
(EUCTR)
18/01/201307/08/2012A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER LIMITEDNULLNot RecruitingFemale: yes
Male: yes
654Phase 3United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;New Zealand;Japan
19EUCTR2011-004578-27-IT
(EUCTR)
18/01/201307/08/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulverative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
545United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan
20EUCTR2011-004581-14-IT
(EUCTR)
18/01/201307/08/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
725United States;Estonia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;India;Hungary;Czech Republic;Canada;Brazil;Denmark;Australia;South Africa;Germany;Netherlands;Latvia;Japan;Korea, Republic of
21EUCTR2011-004581-14-NL
(EUCTR)
10/10/201212/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
22EUCTR2011-004579-35-NL
(EUCTR)
10/10/201212/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
23EUCTR2011-004578-27-PL
(EUCTR)
18/09/201220/06/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
24EUCTR2011-004581-14-PL
(EUCTR)
17/09/201222/06/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc., 235 East 42nd Street, New York, New York 10017, United StatesNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
25EUCTR2011-004579-35-PL
(EUCTR)
17/09/201228/06/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand
26EUCTR2011-004580-79-PL
(EUCTR)
05/08/201212/06/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
27EUCTR2011-004578-27-ES
(EUCTR)
11/07/201209/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
28EUCTR2011-004579-35-ES
(EUCTR)
11/07/201209/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
29EUCTR2011-004581-14-CZ
(EUCTR)
29/06/201208/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;New Zealand
30EUCTR2011-004578-27-CZ
(EUCTR)
29/06/201208/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc,NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
31EUCTR2011-004579-35-CZ
(EUCTR)
29/06/201208/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc,NULLNot RecruitingFemale: yes
Male: yes
545Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
32EUCTR2011-004580-79-CZ
(EUCTR)
26/06/201208/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer IncNULLNot RecruitingFemale: yes
Male: yes
654Phase 3India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy
33EUCTR2011-004579-35-BE
(EUCTR)
08/06/201208/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
34EUCTR2011-004580-79-BE
(EUCTR)
08/06/201207/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
35EUCTR2011-004581-14-BE
(EUCTR)
07/06/201207/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
36EUCTR2011-004578-27-BE
(EUCTR)
06/06/201207/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
37EUCTR2011-004580-79-DE
(EUCTR)
06/06/201228/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
654Phase 3Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia
38EUCTR2011-004581-14-DE
(EUCTR)
05/06/201229/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (Phase III Formulation)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercialFormulation - debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
39EUCTR2011-004578-27-HU
(EUCTR)
30/05/201210/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
40EUCTR2011-004579-35-DE
(EUCTR)
29/05/201221/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
41EUCTR2011-004579-35-LV
(EUCTR)
23/05/201201/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
42EUCTR2011-004580-79-LV
(EUCTR)
23/05/201201/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
43EUCTR2011-004578-27-LV
(EUCTR)
23/05/201201/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
44EUCTR2011-004578-27-DE
(EUCTR)
23/05/201205/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not availble
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
45EUCTR2011-004581-14-LV
(EUCTR)
23/05/201201/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
725Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
46EUCTR2011-004581-14-AT
(EUCTR)
18/05/201227/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
47EUCTR2011-004580-79-ES
(EUCTR)
18/05/201209/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States
48EUCTR2011-004581-14-ES
(EUCTR)
18/05/201214/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
725Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
49EUCTR2011-004578-27-AT
(EUCTR)
18/05/201227/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
50EUCTR2011-004579-35-AT
(EUCTR)
18/05/201221/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
51EUCTR2011-004580-79-AT
(EUCTR)
18/05/201227/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
52EUCTR2011-004581-14-HU
(EUCTR)
10/05/201210/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
53EUCTR2011-004579-35-HU
(EUCTR)
10/05/201210/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
54EUCTR2011-004580-79-HU
(EUCTR)
10/05/201210/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
55EUCTR2011-004580-79-SK
(EUCTR)
03/05/201210/04/2013A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
56EUCTR2011-004581-14-SK
(EUCTR)
02/05/201213/04/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
57EUCTR2011-004579-35-SK
(EUCTR)
02/05/201213/04/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
58EUCTR2011-004578-27-SK
(EUCTR)
02/05/201212/04/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
59EUCTR2011-004579-35-GB
(EUCTR)
01/05/201212/01/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
60EUCTR2011-004581-14-GB
(EUCTR)
01/05/201201/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
61EUCTR2011-004580-79-GB
(EUCTR)
30/04/201214/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
654 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
62EUCTR2011-004578-27-GB
(EUCTR)
26/04/201212/01/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
63EUCTR2011-004578-27-EE
(EUCTR)
26/04/201214/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
64EUCTR2011-004580-79-EE
(EUCTR)
26/04/201213/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
65EUCTR2011-004579-35-EE
(EUCTR)
26/04/201214/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
66EUCTR2011-004581-14-EE
(EUCTR)
26/04/201213/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
67EUCTR2011-004581-14-DK
(EUCTR)
20/03/201209/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
68EUCTR2011-004578-27-DK
(EUCTR)
24/02/201209/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
69EUCTR2011-004580-79-DK
(EUCTR)
24/02/201223/01/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
70EUCTR2011-004579-35-DK
(EUCTR)
24/02/201224/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
71EUCTR2018-002378-30-BE
(EUCTR)
13/12/2021OPEN LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNAFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
72EUCTR2018-002378-30-PL
(EUCTR)
24/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNAFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan;Sweden
73EUCTR2018-002378-30-SK
(EUCTR)
14/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNAFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
74EUCTR2018-002378-30-SE
(EUCTR)
10/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNAFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan;Sweden

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004915-22-NL
(EUCTR)
17/05/202205/02/2021A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;China;Sweden
2EUCTR2017-002018-29-HU
(EUCTR)
04/01/202225/10/2021Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
3EUCTR2017-002018-29-NL
(EUCTR)
19/10/202110/12/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Germany;Netherlands;China;Sweden
4EUCTR2017-002018-29-DE
(EUCTR)
02/02/202123/09/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Eritrea;South Africa;Netherlands;Germany;China;Sweden
5EUCTR2017-002018-29-SK
(EUCTR)
09/12/202004/08/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Germany;Netherlands;China;Sweden
6EUCTR2017-002018-29-PL
(EUCTR)
28/10/202009/08/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;South Africa;Netherlands;Germany;China;Sweden
7EUCTR2015-001438-46-PL
(EUCTR)
16/04/201930/01/2018Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
8EUCTR2015-001438-46-DE
(EUCTR)
16/04/201813/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA PopulationEFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Argentina;Russian Federation;United States;Ukraine;United Kingdom;Switzerland;Spain;Canada;Turkey;Belgium;Brazil;Poland;Mexico;South Africa;Israel;Australia;Chile;Germany
9EUCTR2015-001438-46-ES
(EUCTR)
05/04/201821/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
10EUCTR2011-004915-22-GB
(EUCTR)
03/04/201821/12/2017A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
11EUCTR2015-001438-46-GB
(EUCTR)
27/03/201828/11/2017Efficacy Study Of Tofacitinib In Pediatric JIA PopulationEFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FORTREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHICARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Switzerland;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany
12EUCTR2011-004915-22-BE
(EUCTR)
16/03/201802/01/2018A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNAFemale: yes
Male: yes
340Phase 2;Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany;Netherlands;China;Sweden
13EUCTR2015-001438-46-BE
(EUCTR)
19/02/201806/12/2017Efficacy Study Of Tofacitinib In Pediatric JIA Population EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany
14EUCTR2011-004914-40-IT
(EUCTR)
14/11/201221/09/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THEPHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 INPEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITHJUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Hungary;Mexico;Argentina;Poland;Russian Federation;Italy
15EUCTR2011-004914-40-PL
(EUCTR)
19/09/201216/05/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 17.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy
16EUCTR2011-004915-22-DE
(EUCTR)
17/09/201211/06/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden
17EUCTR2011-004915-22-PL
(EUCTR)
14/09/201221/05/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Trade Name: XELJANZ
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;South Africa;Germany;Netherlands;China;Sweden
18EUCTR2011-004914-40-HU
(EUCTR)
03/08/201217/05/2012AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Poland;Russian Federation;Germany;Italy;Serbia;Czech Republic;Hungary;Slovakia;Mexico;Argentina
19EUCTR2011-004915-22-HU
(EUCTR)
03/08/201217/05/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 15.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Serbia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Germany;Italy
20EUCTR2011-004915-22-SK
(EUCTR)
31/07/201231/07/2012A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 2;Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;Australia;Peru;South Africa;Netherlands;China;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden
21EUCTR2011-004914-40-SK
(EUCTR)
31/07/201231/07/2012A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
24Phase 1Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy
22EUCTR2017-002018-29-BE
(EUCTR)
07/10/2020Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLNAFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden
23EUCTR2011-004915-22-SE
(EUCTR)
24/06/2021A Long-Term, Open-Label, Study for Treatment of JIAA LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) JUVENILE IDIOPATHIC ARTHRITIS (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: XELJANZ
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: Tofacitinib
Other descriptive name: APD421
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
340Phase 2;Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;China;Sweden
24EUCTR2017-002018-29-SE
(EUCTR)
18/06/2021Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulationEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS Systemic Juvenile Idiopathic Arthritis (sJIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Product Name: Tofacitinibe citrate
Product Code: CP-690-550-10 (DMID D1600180)
INN or Proposed INN: tofacitinib
Other descriptive name: APD421
Pfizer Inc. 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-005689-39-SK
(EUCTR)
24/09/201407/07/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
2EUCTR2011-005689-39-NL
(EUCTR)
01/09/201423/06/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Spain;Poland;Russian Federation;Germany;Netherlands;Korea, Republic of
3EUCTR2011-005689-39-DE
(EUCTR)
20/01/201424/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
4EUCTR2011-005689-39-CZ
(EUCTR)
07/08/201323/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
5EUCTR2011-005689-39-HU
(EUCTR)
27/06/201322/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
6EUCTR2011-005689-39-ES
(EUCTR)
26/06/201324/06/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of