Rheumatoid Arthritis Clinical Trial
Official title:
Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)
The purpose of this study is to:
1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in
subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate
(MTX); and
2. determine the tolerability and safety of multiple doses of MDX-1100 in combination with
MTX in subjects with active RA.
This Phase 2, double-blind, placebo-controlled, randomized, multi-dose, multicenter study of
MDX 1100 (anti CXCL10 human monoclonal antibody) in combination with MTX in subjects with
active RA. All subjects will continue to receive stable doses of MTX (10 to 25 mg weekly)
during the study. Eligible subjects (n=70) will be randomized to receive either placebo
(n=35) or MDX-1100 (n=35) at 10 mg/kg intravenously, every other week for a total of 6
doses. Concomitant treatment with stable doses of prednisolone (≤ 10 mg/d, or equivalent)
and non-steroidal anti-inflammatory drugs (NSAIDS) and analgesic drugs will be permitted
during the study, however, the dose should not be changed until after the Day 85 assessment
has been completed unless rescue therapy is required for significant worsening symptoms
prior to Day 85. After Day 85, subjects will be followed until Day 141 only for safety and
pharmacokinetics, and changes to baseline medications or addition of new medication will be
permitted at the Investigator's discretion. Non-steroid anti-inflammatory drugs (NSAIDS) or
analgesics should not be administered prior to disease activity assessments on study visit
days.
Subjects withdrawn prior to Day 85 will be followed for safety for 70 days following their
last dose of study drug.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
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 |