46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | NCT05246280 (ClinicalTrials.gov) | March 2, 2022 | 16/12/2021 | Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFa Therapy Response in Moderate to Severe Active RA | Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: TC99m-tilmanocept | Navidea Biopharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 523 | Phase 3 | United States |
| 2 | EUCTR2020-005096-12-SE (EUCTR) | 31/05/2021 | 09/04/2021 | Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studie | Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad reumatoid artrit: en randomiserad, öppen, non-inferiority klinisk studie | Rheumatoid arthritis MedDRA version: 23.1;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] | Trade Name: Prednisolon Pfizer Product Name: Prednisolon Pfizer INN or Proposed INN: PREDNISOLONE | Karolinska Universitetssjukhuset | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 4 | Sweden | ||
| 3 | NCT04117165 (ClinicalTrials.gov) | March 1, 2021 | 30/9/2019 | Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis | Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid;Biological Therapy | Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care | University Hospital, Grenoble | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | N/A | France |
| 4 | NCT04530305 (ClinicalTrials.gov) | January 7, 2021 | 24/8/2020 | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Rheumatoid Arthritis | Drug: Tofacitinib 5 MG [Xeljanz] | University Hospital, Montpellier | NULL | Recruiting | 18 Years | N/A | All | 60 | France | |
| 5 | ChiCTR2100041777 | 2021-01-01 | 2021-01-05 | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | rheumatoid arthritis | Treatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide; | Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 6 | ChiCTR2100041909 | 2021-01-01 | 2021-01-09 | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Rheumatoid arthritis | Treatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide; | Yunnan Traditional Chinese Medicine Hospital | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 7 | EUCTR2018-004558-30-DK (EUCTR) | 18/12/2020 | 05/10/2020 | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 4 | Portugal;Spain;Denmark | ||
| 8 | NCT04569890 (ClinicalTrials.gov) | December 1, 2020 | 20/9/2020 | Treatment of Pregnancy RA | Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China | Rheumatoid Arthritis;Pregnancy Related | Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone | RenJi Hospital | NULL | Not yet recruiting | 20 Years | 40 Years | Female | 100 | N/A | China |
| 9 | NCT04928066 (ClinicalTrials.gov) | March 1, 2020 | 9/6/2021 | The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA | Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: Tofacitinib;Drug: Pred | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 4 | China |
| 10 | EUCTR2018-004558-30-PT (EUCTR) | 03/02/2020 | 21/05/2019 | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | 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] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 4 | Portugal;Spain | ||
| 11 | NCT04115397 (ClinicalTrials.gov) | January 2020 | 2/10/2019 | Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints | Towards Efficient Prediction and Prevention of Rheumatoid Arthritis | Seropositive Muskuloskeletal Complaints | Drug: Zoledronic Acid;Drug: Placebo | Karolinska Institutet | NULL | Not yet recruiting | 18 Years | N/A | All | 80 | Phase 4 | NULL |
| 12 | EUCTR2018-004287-56-FR (EUCTR) | 21/11/2019 | 31/01/2020 | Methotrexate and Metformin in rheumatoid arthritis patients | Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 | rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METFORMINE ARROW 500mg Product Name: Metformin Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Acide folique Product Name: Acide folique Product Code: B03BB01 Trade Name: Prednisone Product Name: Prednisone Product Code: H02AB07 | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 13 | EUCTR2017-003037-28-NL (EUCTR) | 02/10/2019 | 22/07/2019 | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA | RA patients with active RA despite treatment with DMARDs. MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE INN or Proposed INN: PREDNISOLONE Other descriptive name: Prednisolone | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 14 | NCT03882008 (ClinicalTrials.gov) | May 23, 2019 | 7/11/2018 | A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis | Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept | University of Washington | Bristol-Myers Squibb | Enrolling by invitation | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 15 | EUCTR2018-004558-30-ES (EUCTR) | 16/05/2019 | 11/04/2019 | Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response. | Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response. | 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] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 16 | NCT03981900 (ClinicalTrials.gov) | January 4, 2019 | 7/6/2019 | IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis | IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study. | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 500 | France | |
| 17 | EUCTR2018-001114-15-NL (EUCTR) | 18/09/2018 | 28/05/2018 | Predicting the risk for rheumatoid arthritis with the help of a PET scan. | Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: [18F]PEG-Folate | VU Medical Center, department of Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 18 | NCT03368235 (ClinicalTrials.gov) | January 18, 2018 | 3/11/2017 | Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: AZD9567;Drug: Prednisolone | AstraZeneca | NULL | Completed | 18 Years | 80 Years | All | 21 | Phase 2 | Netherlands;Sweden;Denmark |
| 19 | EUCTR2017-000838-64-NL (EUCTR) | 10/11/2017 | 13/06/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | 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] - Skin and Connective Tissue Diseases [C17] | Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 20 | NCT03337815 (ClinicalTrials.gov) | October 28, 2017 | 22/10/2017 | A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model | Rheumatoid Arthritis | Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Recruiting | 45 Years | 70 Years | All | 264 | Phase 2/Phase 3 | China |
| 21 | EUCTR2017-000838-64-SE (EUCTR) | 11/09/2017 | 19/05/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | 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] - Skin and Connective Tissue Diseases [C17] | Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: - | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 22 | EUCTR2017-000838-64-DK (EUCTR) | 25/08/2017 | 13/06/2017 | An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone | A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA) | 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] - Skin and Connective Tissue Diseases [C17] | Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: - | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Denmark;Netherlands;Sweden | ||
| 23 | EUCTR2011-004720-35-NL (EUCTR) | 22/03/2017 | 22/02/2017 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) 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] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Iceland;Netherlands;Sweden | ||
| 24 | NCT03855007 (ClinicalTrials.gov) | January 1, 2017 | 15/2/2019 | The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred | Qilu Hospital of Shandong University | NULL | Active, not recruiting | 16 Years | 90 Years | All | 200 | Phase 4 | China |
| 25 | NCT03016260 (ClinicalTrials.gov) | December 2016 | 4/1/2017 | RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis | Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination. | RheumatoId Arthritis | Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar | TcLand Expression S.A. | European Commission | Terminated | 18 Years | N/A | All | 250 | Czechia;France;Israel;Netherlands;Turkey;Czech Republic | |
| 26 | EUCTR2015-002729-21-PT (EUCTR) | 12/09/2016 | 27/04/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis 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: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 27 | NCT02930343 (ClinicalTrials.gov) | September 2016 | 13/9/2016 | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy | Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Terminated | 18 Years | 65 Years | All | 136 | Phase 3 | India |
| 28 | EUCTR2016-001618-18-FR (EUCTR) | 08/07/2016 | 09/06/2016 | Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients | STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR | glucocorticoid withdrawal in 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: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg | CHU Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | France | ||
| 29 | NCT02585258 (ClinicalTrials.gov) | June 30, 2016 | 20/10/2015 | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis | RheumatoId Arthritis | Drug: Prednisolone;Other: Placebo | VU University Medical Center | European Commission | Completed | 65 Years | N/A | All | 451 | Phase 4 | Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland |
| 30 | EUCTR2015-002729-21-FI (EUCTR) | 21/06/2016 | 30/03/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis 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: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 31 | NCT02804204 (ClinicalTrials.gov) | June 2016 | 8/6/2016 | Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF | Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Anti-TNF | Hospital Universitari Vall d'Hebron Research Institute | UCB Pharma | Unknown status | 18 Years | N/A | All | 200 | Spain | |
| 32 | EUCTR2015-002729-21-HU (EUCTR) | 04/05/2016 | 11/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis 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] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 33 | NCT02760316 (ClinicalTrials.gov) | May 2, 2016 | 25/4/2016 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567. | A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control | Rheumatoid Arthritis | Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg | AstraZeneca | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 1 | Germany;United Kingdom |
| 34 | EUCTR2015-002729-21-DE (EUCTR) | 25/04/2016 | 02/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA | Rheumatoid artritis 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: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 35 | EUCTR2015-002729-21-SK (EUCTR) | 22/04/2016 | 25/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis 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: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 36 | NCT02770794 (ClinicalTrials.gov) | April 1, 2016 | 11/5/2016 | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis | Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity | Arthritis, Rheumatoid | Drug: Infliximab | Chiba University | NULL | Completed | 18 Years | N/A | All | 211 | Phase 4 | Japan |
| 37 | NCT02573012 (ClinicalTrials.gov) | March 29, 2016 | 1/10/2015 | Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 314 | Phase 4 | France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey |
| 38 | EUCTR2015-002924-17-BE (EUCTR) | 24/02/2016 | 27/01/2016 | A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis | A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol | Sun Pharma Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Belgium;Netherlands | ||
| 39 | EUCTR2014-004673-16-DE (EUCTR) | 12/01/2016 | 15/07/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | 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] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland | ||
| 40 | NCT02878161 (ClinicalTrials.gov) | January 2016 | 12/7/2016 | Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World | Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway | Rheumatoid Arthritis | Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary) | Fen Li | NULL | Enrolling by invitation | 18 Years | 75 Years | Both | 240 | Phase 4 | NULL |
| 41 | NCT02644499 (ClinicalTrials.gov) | December 31, 2015 | 30/12/2015 | Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis | Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Completed | 18 Years | N/A | All | 186 | Phase 4 | India |
| 42 | NCT03172325 (ClinicalTrials.gov) | November 18, 2015 | 24/5/2017 | Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA | A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RA | Active Rheumatoid Arthritis | Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone | Cinnagen | NULL | Completed | 18 Years | 75 Years | All | 136 | Phase 3 | Iran, Islamic Republic of |
| 43 | NCT02512575 (ClinicalTrials.gov) | November 18, 2015 | 6/7/2015 | A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567. | A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects. | Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis | Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone | AstraZeneca | NULL | Completed | 18 Years | 55 Years | Male | 72 | Phase 1 | Germany |
| 44 | EUCTR2014-004673-16-FR (EUCTR) | 16/11/2015 | 05/08/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | 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] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland | ||
| 45 | EUCTR2013-000337-13-PT (EUCTR) | 13/11/2015 | 11/11/2015 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Serbia;Portugal;Germany | ||
| 46 | EUCTR2015-002924-17-NL (EUCTR) | 12/11/2015 | 06/10/2015 | A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis | A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol | Sun Pharma Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Netherlands | ||
| 47 | EUCTR2015-000581-58-CZ (EUCTR) | 14/10/2015 | 16/06/2015 | A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Revmatologicky ustav Praha | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Czech Republic | ||
| 48 | NCT02451748 (ClinicalTrials.gov) | August 2015 | 6/5/2015 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA | Rheumatoid Arthritis | Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira | University of Illinois at Chicago | UCB Pharma | Completed | 18 Years | N/A | All | 32 | Phase 4 | United States |
| 49 | EUCTR2014-001114-26-SE (EUCTR) | 18/02/2015 | 26/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 50 | EUCTR2014-001114-26-NL (EUCTR) | 13/02/2015 | 24/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden | ||
| 51 | NCT02466581 (ClinicalTrials.gov) | February 3, 2015 | 29/5/2015 | Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity | A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity | Rheumatoid Arthritis | Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra | Karolinska Institutet | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 4 | Sweden |
| 52 | NCT03719469 (ClinicalTrials.gov) | January 20, 2015 | 6/9/2018 | Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis | Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea | Rh Disease | Dietary Supplement: Green tea group | King Saud University | NULL | Completed | 18 Years | 85 Years | All | 150 | NULL | |
| 53 | NCT02198651 (ClinicalTrials.gov) | January 5, 2015 | 22/7/2014 | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA) | Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases | Biological: Adalimumab;Other: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 149 | Phase 4 | United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 54 | EUCTR2014-001114-26-GR (EUCTR) | 12/12/2014 | 02/12/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 55 | EUCTR2014-001114-26-IE (EUCTR) | 11/12/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 56 | EUCTR2014-001114-26-GB (EUCTR) | 25/11/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 57 | EUCTR2014-001114-26-ES (EUCTR) | 17/11/2014 | 01/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 58 | EUCTR2014-001114-26-FR (EUCTR) | 13/11/2014 | 18/06/2015 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 59 | EUCTR2014-001114-26-DE (EUCTR) | 10/11/2014 | 08/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Sweden;Netherlands;Germany;Australia;Canada;Hungary;Italy;United Kingdom;Austria;Ireland;Spain;Greece;United States | ||
| 60 | EUCTR2014-001114-26-AT (EUCTR) | 05/11/2014 | 10/10/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 61 | JPRN-UMIN000015616 | 2014/11/04 | 10/11/2014 | Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction | rheumatoid arthritis | Adalimumab plus Methotrexate Tocilizumab plus Methotrexate | Biologic Mate Study Group | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 300 | Not selected | Japan | |
| 62 | EUCTR2014-001114-26-HU (EUCTR) | 04/11/2014 | 10/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 63 | NCT02287610 (ClinicalTrials.gov) | November 2014 | 6/11/2014 | A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis | A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting | Rheumatoid Arthritis | Drug: RAYOS (delayed-release prednisone) | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | N/A | All | 75 | N/A | NULL |
| 64 | EUCTR2014-001114-26-IT (EUCTR) | 20/10/2014 | 16/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 65 | NCT01717859 (ClinicalTrials.gov) | September 2014 | 19/10/2012 | Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab | Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | University of California, Los Angeles | Genentech, Inc. | Completed | 18 Years | N/A | All | 74 | Phase 4 | United States |
| 66 | NCT02202837 (ClinicalTrials.gov) | August 12, 2014 | 15/7/2014 | Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice | Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered)) | Rheumatoid Arthritis | Drug: etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 157 | Belgium | |
| 67 | NCT04752748 (ClinicalTrials.gov) | August 2014 | 10/2/2021 | Power Doppler in Hand Joints of Early RA Patients | Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment | Early Rheumatoid Arthritis | Drug: Drug protocol | Federal University of São Paulo | NULL | Completed | 18 Years | 65 Years | Female | 48 | NULL | |
| 68 | NCT02000336 (ClinicalTrials.gov) | January 2014 | 19/11/2013 | Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis | Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial | Progression of Rheumatoid Arthritis | Drug: Prednisolone;Drug: Placebo | Prof. Dr. rer. nat. H.J. Trampisch | Ruhr University of Bochum | Completed | 18 Years | N/A | All | 395 | Phase 3 | Germany |
| 69 | EUCTR2013-003658-26-NL (EUCTR) | 13/11/2013 | 18/10/2013 | Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study | Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study | Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 70 | EUCTR2012-004074-25-DE (EUCTR) | 30/10/2013 | 29/07/2013 | Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis | Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA | Early 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] - Musculoskeletal Diseases [C05] | Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon | Ruhr-Universität Bochum | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Germany | ||
| 71 | NCT02072200 (ClinicalTrials.gov) | September 2013 | 14/2/2014 | Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) | A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness | Rheumatoid Arthritis | Drug: Lodotra® | Mundipharma Korea Ltd | NULL | Completed | 20 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 72 | NCT01864265 (ClinicalTrials.gov) | July 2013 | 21/5/2013 | Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain | Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain. A Multi-center, Randomized Double-blind Controlled Study Prediction of Response to Certolizumab-Pegol in RA (PreCePRA) | Rheumatoid Arthritis | Drug: Certolizumab Pegol;Drug: Placebo | University of Erlangen-Nürnberg Medical School | NULL | Completed | 18 Years | N/A | All | 156 | Phase 3 | Germany;Portugal;Serbia;Belgium;United Kingdom;United States |
| 73 | EUCTR2013-000337-13-DE (EUCTR) | 13/05/2013 | 12/02/2013 | Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA) | Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) | Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy 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] | Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Serbia;Portugal;Germany | ||
| 74 | JPRN-UMIN000010126 | 2013/02/25 | 26/02/2013 | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD | Interstitial lung disease related to rheumatoid arthritis | In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases. | Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 34 | Not applicable | Japan |
| 75 | JPRN-UMIN000009088 | 2012/11/01 | 12/10/2012 | Bio Logic MateTM clinical performance test for IFX Efficacy prediction | rheumatoid arthritis | IFX plus methotrexate | Bio Logic Mate Study Group | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 150 | Not selected | Japan | |
| 76 | JPRN-UMIN000010315 | 2012/10/01 | 26/03/2013 | Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment | Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study | rheumatoid arthritis | In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab. | Osaka City University Medical School | Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital. | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 77 | EUCTR2011-005204-15-AT (EUCTR) | 20/06/2012 | 15/05/2012 | Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped? | Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop | biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT | Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | Austria | ||
| 78 | EUCTR2012-000139-21-AT (EUCTR) | 14/05/2012 | 23/04/2012 | Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB | Medizinische Universität Wien, Universitätsklinik für Innere Medizin III | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Czech Republic;Slovakia;Austria;Russian Federation;Switzerland | |||
| 79 | NCT01638715 (ClinicalTrials.gov) | May 2012 | 3/7/2012 | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | Rheumatoid Arthritis | Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera | Medical University of Vienna | NULL | Completed | 18 Years | 75 Years | All | 115 | Phase 4 | Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia |
| 80 | NCT01724268 (ClinicalTrials.gov) | May 2012 | 7/11/2012 | Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient | Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study | RHEUMATOID ARTHRITIS | Drug: Pred + Meth;Drug: Anti TNF + Meth | Hamad Medical Corporation | NULL | Recruiting | 18 Years | N/A | Both | 80 | Phase 3 | Qatar |
| 81 | EUCTR2011-002392-41-BG (EUCTR) | 09/04/2012 | 07/02/2012 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | ||
| 82 | EUCTR2011-002392-41-HU (EUCTR) | 28/03/2012 | 16/12/2011 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Bulgaria;Peru;Poland;Brazil;Argentina;Canada;Mexico;Hungary;Russian Federation;Chile;Ukraine;United States;Serbia | ||
| 83 | NCT01612377 (ClinicalTrials.gov) | March 2012 | 22/2/2012 | Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis | A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone | Zalicus | NULL | Terminated | 18 Years | N/A | Both | 18 | Phase 2 | Serbia |
| 84 | NCT01395251 (ClinicalTrials.gov) | February 2012 | 12/7/2011 | Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis | Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone | Rheumazentrum Ruhrgebiet | NULL | Completed | 18 Years | N/A | Both | 130 | Phase 2/Phase 3 | Germany |
| 85 | EUCTR2010-023782-22-SK (EUCTR) | 25/01/2012 | 07/10/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 86 | EUCTR2010-023782-22-BG (EUCTR) | 21/12/2011 | 21/05/2012 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 87 | EUCTR2011-002633-19-DE (EUCTR) | 21/12/2011 | 02/08/2011 | Prednisolone test for patients with an inflammatory joint disease | Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort | rheumatoid arthritis MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Product Name: Paracetamol INN or Proposed INN: PARACETAMOL | Rheumazentrum Ruhrgebiet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 88 | EUCTR2010-023782-22-ES (EUCTR) | 16/12/2011 | 20/07/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer, S.L.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland | ||
| 89 | EUCTR2010-023782-22-DE (EUCTR) | 13/12/2011 | 16/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 90 | EUCTR2011-000436-28-PL (EUCTR) | 07/12/2011 | 20/06/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation | ||
| 91 | NCT01443364 (ClinicalTrials.gov) | December 2011 | 27/9/2011 | Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis | Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Biological: Certolizumab pegol | UCB Italy s.p.a. | NULL | Completed | 18 Years | N/A | All | 132 | Phase 4 | Italy |
| 92 | EUCTR2011-001220-38-DE (EUCTR) | 30/11/2011 | 21/07/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;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 Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United Kingdom;Germany;Russian Federation;Belgium;United States | |||
| 93 | EUCTR2010-023782-22-HU (EUCTR) | 22/11/2011 | 27/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 94 | EUCTR2011-000436-28-BG (EUCTR) | 07/10/2011 | 06/10/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 95 | NCT04169100 (ClinicalTrials.gov) | September 28, 2011 | 14/11/2019 | Novel Form of Acquired Long QT Syndrome | Novel Form of Acquired Long QT Syndrome | Long QT Syndrome;Connective Tissue Diseases;Rheumatoid Arthritis | Drug: Prednisone | Narrows Institute for Biomedical Research | VA New York Harbor Healthcare System | Recruiting | 18 Years | 89 Years | All | 25 | Phase 4 | United States |
| 96 | EUCTR2010-023782-22-CZ (EUCTR) | 21/09/2011 | 01/08/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 97 | EUCTR2011-001220-38-BE (EUCTR) | 19/09/2011 | 30/08/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.1;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 Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 98 | NCT01393639 (ClinicalTrials.gov) | September 2011 | 13/6/2011 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug. | Rheumatoid Arthritis | Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 323 | Phase 2 | United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic |
| 99 | EUCTR2011-000385-35-IT (EUCTR) | 19/08/2011 | 27/02/2012 | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY - CZP-SPEED | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: CIMZIA INN or Proposed INN: CERTOLUZIMAB PEGOL Other descriptive name: NA | UCB PHARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 100 | EUCTR2011-000436-28-HU (EUCTR) | 02/08/2011 | 10/08/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 101 | EUCTR2011-001220-38-GB (EUCTR) | 12/07/2011 | 17/05/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;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 Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 102 | NCT01369745 (ClinicalTrials.gov) | June 2011 | 7/6/2011 | A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo | Zalicus | NULL | Completed | 18 Years | N/A | All | 294 | Phase 2 | United States |
| 103 | NCT01382160 (ClinicalTrials.gov) | January 2011 | 2/12/2010 | Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA) | Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA) | Rheumatoid Arthritis | Biological: adalimumab | University Hospital, Tours | NULL | Completed | 18 Years | N/A | Both | 69 | Phase 4 | France |
| 104 | NCT01255761 (ClinicalTrials.gov) | November 2010 | 6/12/2010 | A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects | Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia | Rheumatoid Arthritis | Biological: Certolizumab Pegol (CZP) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 736 | Phase 4 | United States |
| 105 | EUCTR2009-015740-42-DE (EUCTR) | 12/05/2010 | 12/01/2010 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A | Universitätsklinkum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 3 | Germany | ||
| 106 | EUCTR2009-013223-37-ES (EUCTR) | 25/11/2009 | 17/09/2009 | Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | ARTRITIS REUMATOIDE MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer S.A. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Czech Republic;Spain | ||
| 107 | EUCTR2009-013223-37-CZ (EUCTR) | 10/11/2009 | 17/08/2009 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Czech Republic;Spain | ||
| 108 | EUCTR2009-013223-37-HU (EUCTR) | 16/10/2009 | 02/09/2009 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Spain | ||
| 109 | NCT00938587 (ClinicalTrials.gov) | October 2009 | 13/7/2009 | A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: PF-04171327 10 mg;Other: Prednisone Placebo;Drug: PF-04171327 25 mg;Drug: Prednisone 5 mg;Other: Placebo for PF-04171327;Other: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 86 | Phase 2 | United States;Czechia;Hong Kong;Hungary;Korea, Republic of;Russian Federation;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic |
| 110 | NCT01075711 (ClinicalTrials.gov) | April 2009 | 24/2/2010 | Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone) | Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet | Arthritis, Rheumatoid | Drug: Prednisone | Merck KGaA | Merck Serono GmbH, Germany | Completed | 18 Years | N/A | Both | 2728 | N/A | Germany |
| 111 | NCT01172639 (ClinicalTrials.gov) | February 2009 | 28/7/2010 | Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Prednisone | P. Verschueren | Agentschap voor Innovatie door Wetenschap en Technologie | Completed | 18 Years | N/A | All | 400 | Phase 4 | Belgium |
| 112 | EUCTR2007-006150-25-DE (EUCTR) | 09/01/2009 | 26/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria | |||
| 113 | EUCTR2007-006150-25-AT (EUCTR) | 03/12/2008 | 07/10/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
| 114 | EUCTR2007-006150-25-NL (EUCTR) | 01/12/2008 | 02/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
| 115 | EUCTR2007-006150-25-BE (EUCTR) | 05/09/2008 | 24/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;Hungary;Belgium;Austria;Netherlands;Germany | ||
| 116 | NCT00746512 (ClinicalTrials.gov) | September 2008 | 3/9/2008 | A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088) | A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated Tablets | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 45 | Phase 1 | United Kingdom |
| 117 | EUCTR2007-006150-25-HU (EUCTR) | 04/07/2008 | 01/04/2009 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany | |||
| 118 | EUCTR2007-003508-36-GB (EUCTR) | 02/07/2008 | 29/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Germany;United Kingdom | ||
| 119 | EUCTR2007-004399-38-LT (EUCTR) | 26/06/2008 | 23/04/2008 | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | United Kingdom;Estonia;Lithuania | |||
| 120 | EUCTR2007-006150-25-FR (EUCTR) | 24/06/2008 | 05/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;Hungary;Belgium;Austria;Netherlands;Germany | ||
| 121 | EUCTR2007-003508-36-HU (EUCTR) | 17/06/2008 | 18/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 122 | EUCTR2007-003508-36-DE (EUCTR) | 25/04/2008 | 28/03/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 123 | EUCTR2007-004399-38-EE (EUCTR) | 18/04/2008 | 29/02/2008 | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | United Kingdom;Estonia;Lithuania | |||
| 124 | EUCTR2007-003069-42-LT (EUCTR) | 01/04/2008 | 05/02/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;United Kingdom;Estonia;Lithuania | |||
| 125 | EUCTR2007-003069-42-HU (EUCTR) | 27/03/2008 | 18/09/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;United Kingdom;Estonia;Lithuania | |||
| 126 | EUCTR2007-004399-38-GB (EUCTR) | 03/03/2008 | 20/03/2008 | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | United Kingdom;Estonia;Lithuania | |||
| 127 | NCT00634933 (ClinicalTrials.gov) | March 2008 | 5/3/2008 | Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate | Arthritis, Rheumatoid | Drug: TRU-015;Drug: Methylprednisolone;Drug: Prednisone | Pfizer | Trubion Pharmaceuticals/Emergent BioSolutions Inc. | Terminated | 18 Years | N/A | All | 222 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Mexico;Netherlands;Romania;Serbia;Austria |
| 128 | NCT00650078 (ClinicalTrials.gov) | March 2008 | 28/3/2008 | Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis | A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MR prednisone;Drug: Placebo | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | 80 Years | All | 350 | Phase 3 | United States;Canada;Germany;Hungary;Poland;United Kingdom |
| 129 | EUCTR2007-006729-28-GB (EUCTR) | 25/01/2008 | 04/12/2007 | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Kenalog Product Name: Triamcinolone acetonide INN or Proposed INN: TRIAMCINOLONE ACETONIDE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE | Trafford NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 58 | United Kingdom | |||
| 130 | EUCTR2007-003069-42-GB (EUCTR) | 24/01/2008 | 15/08/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;United Kingdom;Estonia;Lithuania | |||
| 131 | NCT00580229 (ClinicalTrials.gov) | December 2007 | 18/12/2007 | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: prednisone | University of South Florida | NULL | Completed | 18 Years | 80 Years | All | 50 | Phase 2/Phase 3 | United States |
| 132 | EUCTR2007-003069-42-EE (EUCTR) | 31/10/2007 | 10/08/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA) | RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole | CombinatoRx, Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;United Kingdom;Estonia;Lithuania | |||
| 133 | NCT00551707 (ClinicalTrials.gov) | October 2007 | 29/10/2007 | Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360) | Zalicus | NULL | Completed | 18 Years | N/A | All | 51 | Phase 2 | United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa |
| 134 | EUCTR2007-002976-32-NL (EUCTR) | 06/09/2007 | 30/08/2007 | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light). | Trade Name: Prednisone Trade Name: Methotrexate Trade Name: Sulphasalazine | TIPharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 135 | NCT03414502 (ClinicalTrials.gov) | August 2007 | 2/1/2014 | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Abatacept;Drug: Adalimumab;Drug: Azathioprine;Drug: Baricitinib;Drug: Certolizumab;Drug: Etanercept;Drug: Golimumab;Drug: Hydroxychloroquine;Drug: Infliximab;Drug: Leflunomide;Drug: Minocycline;Drug: Rituximab;Drug: Sarilumab;Drug: Sulfasalazine;Drug: Tofacitinib | University of Nebraska | NULL | Recruiting | 19 Years | N/A | All | 400 | Phase 3 | United States |
| 136 | EUCTR2007-001190-28-GB (EUCTR) | 09/05/2007 | 17/04/2007 | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: Sulfasalazine Product Code: Sulfasalazine INN or Proposed INN: SULFASALAZINE Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Product Name: Ciclosporin Product Code: Ciclosporin INN or Proposed INN: Ciclosporin Product Name: Leflunomide Product Code: Leflunomide INN or Proposed INN: Leflunomide Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) INN or Proposed INN: Sodium aurothiomalate Product Name: methylprednisolone Product Code: methylprednisolone INN or Proposed INN: Methylprednisolone Product Name: Prednisolone Product Code: Predniso | King's College London | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 4 | United Kingdom | ||
| 137 | NCT00480272 (ClinicalTrials.gov) | May 2007 | 29/5/2007 | Prospective Study on Intensive Early Rheumatoid Arthritis Treatment | A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance | Rheumatoid Arthritis | Drug: adalimumab, plus prednisone;Drug: adalimumab plus placebo | IRCCS Policlinico S. Matteo | NULL | Completed | 18 Years | 70 Years | All | 251 | Phase 4 | Italy |
| 138 | NCT00443430 (ClinicalTrials.gov) | May 2007 | 2/3/2007 | Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis | Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) | Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis | Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm | Seattle Children's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Amgen | Completed | 2 Years | 17 Years | All | 85 | Phase 4 | United States |
| 139 | EUCTR2006-006186-16-NL (EUCTR) | 30/01/2007 | 16/07/2007 | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | rheumatoid arthritis and undifferentiated arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: MTX INN or Proposed INN: METHOTREXATE Product Name: Prednisone INN or Proposed INN: PREDNISONE Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Trade Name: hydroxychloroquine Product Name: hydroxychloroquine Product Code: HCQ INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE Trade Name: Humira Product Name: adalimumab | Leiden University Medical Center, department of rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 140 | EUCTR2006-003843-22-IT (EUCTR) | 24/10/2006 | 30/08/2006 | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study | rheumatoid arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab Trade Name: METHOTREXATE*100CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Italy | |||
| 141 | EUCTR2004-001930-18-EE (EUCTR) | 17/04/2006 | 19/01/2006 | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA | RHEUMATOID ARTHRITIS | Trade Name: Persantin 100 mg and Product Name: N/A Product Code: CRx-102 INN or Proposed INN: prednisolone & dipyridamole | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Estonia | |||
| 142 | EUCTR2004-004995-35-DK (EUCTR) | 10/04/2006 | 20/09/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Germany;United Kingdom;Denmark;Italy | ||
| 143 | EUCTR2004-004995-35-GB (EUCTR) | 24/02/2006 | 16/03/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom | ||
| 144 | EUCTR2005-004385-16-GB (EUCTR) | 03/01/2006 | 08/12/2005 | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | Rheumatoid arthritis | Product Name: Prednisone INN or Proposed INN: Prednisone | United Bristol Healthcare NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 12 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 145 | NCT03496831 (ClinicalTrials.gov) | January 1, 2006 | 5/4/2018 | Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs | Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis | Drug: Biologic Agents | Simon Krabbe | University of Aarhus;Zealand University Hospital;University of Southern Denmark | Completed | 18 Years | N/A | All | 7500 | NULL | |
| 146 | NCT00234234 (ClinicalTrials.gov) | January 2006 | 5/10/2005 | Predictors of the Response to Adalimumab in Rheumatoid Arthritis | Predictors of the Response to Adalimumab in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 200 | Phase 4 | France |
| 147 | NCT00379990 (ClinicalTrials.gov) | January 2006 | 21/9/2006 | A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days. | A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects. | Arthritis, Rheumatoid | Drug: GW274150;Drug: Prednisolone;Other: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | Both | 48 | Phase 2 | Serbia;United Kingdom |
| 148 | EUCTR2005-000902-30-GB (EUCTR) | 09/12/2005 | 05/08/2005 | A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients | A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients | Rheumatoid arthritis | Trade Name: Prednisolone Tablets USP 5 mg Product Name: Prednisolone Tablets USP 5 mg INN or Proposed INN: Prednisolone | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 149 | NCT00705289 (ClinicalTrials.gov) | December 2005 | 23/6/2008 | A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) | Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice | Rheumatoid Arthritis | Biological: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | N/A | N/A | All | 728 | N/A | NULL |
| 150 | EUCTR2004-004995-35-IT (EUCTR) | 08/11/2005 | 02/02/2007 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD | Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment. MedDRA version: 6.1;Level: PT;Classification code 10039073 | INN or Proposed INN: Paroxetine INN or Proposed INN: Paroxetine Trade Name: Prednisolene tablets BP 1 mg INN or Proposed INN: Prednisolone | COMBINATORX, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Germany;United Kingdom;Denmark;Italy | ||
| 151 | EUCTR2004-004995-35-AT (EUCTR) | 16/10/2005 | 09/11/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 152 | NCT00241982 (ClinicalTrials.gov) | October 2005 | 18/10/2005 | Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis | Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: long-circulating liposomal prednisolone | Radboud University | Utrecht University | Completed | 18 Years | N/A | Both | 22 | Phase 2 | Netherlands |
| 153 | EUCTR2004-005115-29-DE (EUCTR) | 14/09/2005 | 16/05/2006 | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | Rheumatoid arthritis | Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: Overencapsulated Prednisolone Tablets INN or Proposed INN: Prednisolone | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 77 | United Kingdom;Germany | |||
| 154 | EUCTR2005-001977-82-GB (EUCTR) | 09/09/2005 | 14/07/2005 | A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects | A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects | Rheumatoid arthritis | Product Name: GW274150 Tablets Product Code: GW274150 Trade Name: Deltacortril Enteric Product Name: Prednisolone INN or Proposed INN: Prednisolone | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 155 | EUCTR2004-004995-35-CZ (EUCTR) | 30/08/2005 | 30/08/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Trade Name: Prednisolone Tablets BP 1 mg Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Germany;United Kingdom;Czech Republic;Denmark;Italy | ||
| 156 | EUCTR2004-004995-35-DE (EUCTR) | 14/07/2005 | 17/03/2005 | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA | ACTIVE RHEUMATOID ARTHRITIS | Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine Product Name: N/A Product Code: CRX-139 INN or Proposed INN: Prednisolone Product Name: N/A Product Code: CRX-139 INN or Proposed INN: paroxetine | CombinatoRx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Czech Republic;United Kingdom;Germany;Denmark;Italy | ||
| 157 | EUCTR2004-005115-29-GB (EUCTR) | 24/06/2005 | 27/05/2005 | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship | Rheumatoid arthritis | Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323 Trade Name: Prednisolone Tablets BP Product Name: Overencapsulated Prednisolone Tablets INN or Proposed INN: Prednisolone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 77 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;United Kingdom | ||
| 158 | NCT00134693 (ClinicalTrials.gov) | June 21, 2005 | 24/8/2005 | A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis | A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship | Arthritis, Rheumatoid | Drug: Prednisolone;Drug: SB-681323 | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | Australia;France;Germany;Russian Federation;United Kingdom |
| 159 | NCT00146640 (ClinicalTrials.gov) | August 31, 2004 | 6/9/2005 | Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis | A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only | Rheumatoid Arthritis | Drug: MR Prednisone;Drug: IR Prednisone;Drug: Placebo - MR Prednisone;Drug: Placebo - IR Prednisone | Merck KGaA, Darmstadt, Germany | NULL | Completed | 18 Years | 80 Years | All | 288 | Phase 3 | Germany;Poland |
| 160 | NCT00213538 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Response to anakinra associated with methotrexate | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | All | 341 | N/A | France |
| 161 | NCT00213564 (ClinicalTrials.gov) | April 2003 | 13/9/2005 | Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis | Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: response to infliximab associated with methotrexate | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 40 | France | |
| 162 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States |