Rheumatoid Arthritis Clinical Trial
Official title:
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822
This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
The primary objective of this extension study was to assess the long-term safety of 8 mg/kg
tocilizumab with regard to adverse events (AEs) and laboratory result abnormalities.
The secondary objectives were as follows:
- To explore the possibility of reducing concomitant steroid treatment
- To determine the long-term efficacy of 8 mg/kg tocilizumab with regard to reduction in
signs and symptoms
- To better understand and predict tocilizumab efficacy, response, safety, and
progression of rheumatoid arthritis (RA) and associated diseases with regard to its
effect on biomarkers
No viable biomarkers for TCZ treatment effects were identified from the controlled studies.
There were, therefore, no biomarkers that warranted further investigation in long-term
studies, so no biomarker data are reported.
The extension study WA18695 was an open-label, international multi-center study in patients
with moderate to severe active rheumatoid arthritis (RA) who had completed treatment in the
24 weeks placebo-controlled Phase III study WA17822. Patients entering WA17822 had an
inadequate response to methotrexate (MTX), and, during WA17822, patients had received
treatment with intravenous infusions of tocilizumab 4 mg/kg, 8 mg/kg, or placebo every 4
weeks with background MTX therapy.
All patients who completed the planned course of treatment or escape therapy in the WA17822
study were eligible to enter the WA18695 long-term extension study, where they were assigned
to treatment with 8 mg/kg RoActemra/Actemra plus MTX. The dose of RA medications such as MTX
and nonsteroidal anti-inflammatory drugs (NSAIDs), but excluding corticosteroids, was to be
kept stable for the first 48 weeks of the WA18695 study. During this time dose reductions in
these treatments were only allowed as clinically required for safety reasons. After week 48,
the administration of disease-modifying antirheumatic drugs (DMARDs) and NSAIDs could be
changed, according to the investigator's practice and as tolerated by the patient.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 |
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 |