46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | 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 | EUCTR2013-005418-37-DE (EUCTR) | 05/02/2015 | 24/07/2014 | A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment. MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Dekavil Product Code: F8IL10 INN or Proposed INN: dekavil Other descriptive name: F8IL10 | Philogen S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy;Switzerland | ||
| 2 | NCT02270632 (ClinicalTrials.gov) | October 1, 2014 | 16/10/2014 | A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate. | Rheumatoid Arthritis | Drug: F8IL10;Drug: MTX;Drug: Placebo | Philogen S.p.A. | NULL | Active, not recruiting | 18 Years | 74 Years | All | 27 | Phase 2 | Germany;Italy;Switzerland |
| 3 | EUCTR2013-005418-37-IT (EUCTR) | 15/09/2014 | 06/03/2014 | A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate. | Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Dekavil Product Code: F8IL10 INN or Proposed INN: dekavil Other descriptive name: F8IL10 | Philogen S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 87 | Phase 2 | Germany;Italy | ||
| 4 | NCT02076659 (ClinicalTrials.gov) | September 2011 | 24/2/2014 | Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients | A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: F8IL10;Drug: Methotrexate | Philogen S.p.A. | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 1 | Italy |