Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
Phase 4
Terminated
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00233558
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
Exclusion Criteria
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Corticoid reduction and DAS 28
- Secondary Outcome Measures
Name Time Method Patient reported outcomes Clinical response indicators Safety parameters
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which adalimumab and methotrexate modulate inflammation in rheumatoid arthritis patients during steroid reduction?
How does the scheduled steroid reduction strategy in NCT00233558 compare to physician-led approaches in terms of clinical outcomes and remission rates in active RA patients?
Which biomarkers are associated with sustained response to adalimumab plus methotrexate in rheumatoid arthritis when combined with steroid tapering?
What are the potential adverse events and management strategies for patients undergoing steroid reduction with adalimumab and methotrexate in phase 4 RA trials?
How do adalimumab and methotrexate combination therapies compare to other biologic agents like etanercept or infliximab in managing active rheumatoid arthritis with steroid tapering?
Trial Locations
- Locations (1)
Global Medical Information - Abbott
🇺🇸North Chicago, Illinois, United States
Global Medical Information - Abbott🇺🇸North Chicago, Illinois, United States