Rheumatoid Arthritis Clinical Trial
Official title:
A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
Verified date | January 2009 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
Status | Completed |
Enrollment | 127 |
Est. completion date | April 2006 |
Est. primary completion date | August 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion criteria - Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR) - Disease duration of 6 months or more - Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug - Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL Exclusion criteria - Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug - Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug - Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug. 1. Administration of any DMARD or immunosuppressant other than MTX 2. Administration of corticosteroids exceeding 10 mg/day as prednisolone 3. Dose escalation or initiation of corticosteroids - Received any of the following therapies in the 4 weeks preceding treatment with the study drug 1. Plasma exchange therapy 2. Surgical treatment (operation, etc.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of ACR 20% improvement | week 24 | No | |
Secondary | Frequency and severity of adverse events and adverse drug reactions | throughout study | Yes | |
Secondary | Time course of DAS28 | throughout study | No | |
Secondary | time course of the frequency of ACR 20%, 50% and 70% | throughout study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |