107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details
臨床試験数 : 441 / 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002018-29-HU (EUCTR) | 04/01/2022 | 25/10/2021 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United 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 | ||
| 2 | EUCTR2017-002018-29-NL (EUCTR) | 19/10/2021 | 10/12/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden | ||
| 3 | EUCTR2017-002018-29-DE (EUCTR) | 02/02/2021 | 23/09/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United 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 | ||
| 4 | EUCTR2017-002018-29-IT (EUCTR) | 15/12/2020 | 06/11/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 Product Name: tofacitinib citrate Product Code: [CCP-690-550-10] INN or Proposed INN: Tofacitinib | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Poland;South Africa;Netherlands;Germany;China;Sweden | ||
| 5 | EUCTR2017-002018-29-SK (EUCTR) | 09/12/2020 | 04/08/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Costa Rica;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;China;Sweden | ||
| 6 | EUCTR2017-002018-29-PL (EUCTR) | 28/10/2020 | 09/08/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United 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 | ||
| 7 | EUCTR2015-001438-46-PL (EUCTR) | 16/04/2019 | 30/01/2018 | Efficacy 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 10017 | NULL | Not 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): no | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 8 | NCT03000439 (ClinicalTrials.gov) | May 10, 2018 | 9/11/2016 | A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Arthritis Juvenile Idiopathic | Drug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio | Pfizer | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;China;Costa Rica;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile |
| 9 | EUCTR2015-001438-46-DE (EUCTR) | 16/04/2018 | 13/12/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 10 | EUCTR2015-001438-46-ES (EUCTR) | 05/04/2018 | 21/12/2017 | Efficacy 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 10017 | NULL | Not 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): no | Germany;South Africa;Australia;Brazil;Belgium;Poland;Argentina;Canada;Mexico;United Kingdom;Switzerland;Chile;Israel;Russian Federation;Turkey;Ukraine;Spain;United States | ||
| 11 | EUCTR2011-004915-22-GB (EUCTR) | 03/04/2018 | 21/12/2017 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | New Zealand;Germany;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Turkey;South Africa;Peru;Australia;Switzerland;Italy;Russian Federation;Chile;Israel;Ukraine;Spain;Slovakia;Taiwan;Philippines;United States | ||
| 12 | EUCTR2015-001438-46-GB (EUCTR) | 27/03/2018 | 28/11/2017 | Efficacy Study Of Tofacitinib In Pediatric JIA Population | EFFICACY, 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. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Switzerland;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;South Africa;Germany | ||
| 13 | EUCTR2011-004915-22-BE (EUCTR) | 16/03/2018 | 02/01/2018 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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, 235 East 42nd Street, New York, New York 10017 | NULL | NA | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;India;Peru;Australia;South Africa;Netherlands;China;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand;Sweden | ||
| 14 | EUCTR2015-001438-46-BE (EUCTR) | 19/02/2018 | 06/12/2017 | Efficacy 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 10017 | NULL | Not 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): no | United States;Spain;Ukraine;Turkey;Russian Federation;Israel;Chile;Switzerland;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;South Africa;Germany | ||
| 15 | NCT02592434 (ClinicalTrials.gov) | June 10, 2016 | 14/8/2015 | Efficacy 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 | Drug: CP-690,550 (tofacitinib);Other: placebo | Pfizer | NULL | Completed | 2 Years | 17 Years | All | 225 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Israel;Mexico;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom;Chile;Germany;South Africa;Switzerland |
| 16 | EUCTR2011-004915-22-IT (EUCTR) | 22/07/2013 | 21/09/2012 | A long-term, open label, study for treatment of JIA | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FORTREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | JUVENILE IDIOPATHIC ARTHRITIS (JIA) 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 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: Tofacitinib | PFIZER INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Hungary;Mexico;Argentina;Poland;Russian Federation;Germany;Italy | |||
| 17 | NCT01500551 (ClinicalTrials.gov) | March 18, 2013 | 22/12/2011 | Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) | Juvenile Idiopathic Arthritis | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 2 Years | 18 Years | All | 340 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Germany;Israel;Mexico;Poland;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Chile;Hungary;Switzerland |
| 18 | EUCTR2011-004914-40-IT (EUCTR) | 14/11/2012 | 21/09/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients aged 2-18 | AN 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. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Hungary;Mexico;Argentina;Poland;Russian Federation;Italy | ||
| 19 | EUCTR2011-004914-40-PL (EUCTR) | 19/09/2012 | 16/05/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18 | 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: 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 20 | EUCTR2011-004915-22-DE (EUCTR) | 17/09/2012 | 11/06/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United 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 | ||
| 21 | EUCTR2011-004915-22-PL (EUCTR) | 14/09/2012 | 21/05/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Australia;Peru;South Africa;Bosnia and Herzegovina;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 22 | EUCTR2011-004914-40-HU (EUCTR) | 03/08/2012 | 17/05/2012 | 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) | 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Poland;Russian Federation;Germany;Italy;Serbia;Czech Republic;Hungary;Slovakia;Mexico;Argentina | ||
| 23 | EUCTR2011-004915-22-HU (EUCTR) | 03/08/2012 | 17/05/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Serbia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Germany;Italy | |||
| 24 | EUCTR2011-004915-22-SK (EUCTR) | 31/07/2012 | 31/07/2012 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United 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 | ||
| 25 | EUCTR2011-004914-40-SK (EUCTR) | 31/07/2012 | 31/07/2012 | A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18 | 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: 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | Serbia;Hungary;Czech Republic;Mexico;Slovakia;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 26 | EUCTR2011-004915-22-NL (EUCTR) | 05/02/2021 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 10017 | NULL | NA | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United 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 | |||
| 27 | EUCTR2017-002018-29-BE (EUCTR) | 07/10/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United 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 | |||
| 28 | EUCTR2011-004915-22-SE (EUCTR) | 24/06/2021 | A Long-Term, Open-Label, Study for Treatment of JIA | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 2;Phase 3 | United 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 | |||
| 29 | EUCTR2017-002018-29-SE (EUCTR) | 18/06/2021 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United 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 |