Status:
TERMINATED
Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose ...
Detailed Description
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha...
Eligibility Criteria
Inclusion
- Diagnosis of Rheumatoid Arthritis
- Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization
- Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4
- Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:
- Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly.
- Leflunomide - maximum dose of 20 mg PO daily.
- Sulfasalazine - maximum dose of 1,500 mg PO twice daily.
- Hydroxychloroquine - maximum dose of 400 mg PO daily.
- If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.
- If treated with prednisone (or equivalent corticosteroid), on a stable dose of \<= 10 mg/day for 28 days prior to randomization.
- Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
Exclusion
- Diagnosis of another autoimmune disease likely to require immunosuppression. More information on this criterion can be found in the protocol.
- Failing treatment with etanercept if previously treated with adalimumab
- Failing treatment with adalimumab if previously treated with etanercept
- Intraarticular injection within 4 weeks prior to randomization
- Concomitant use of DMARDs other than those described in Inclusion Criteria within 12 weeks of randomization.
- Concurrent use of any biologic agent other than etanercept or adalimumab
- Concomitant immunosuppressive therapy other than the Disease-Modifying Anti-Rheumatic Drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), or corticosteroids specified in the protocol
- Presence of open leg ulcers
- Chronic or persistent infection that may be worsened by immunosuppressive treatment. More information on this criterion can be found in the protocol.
- Active infection or severe infections requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 30 days prior to randomization
- History of positive Purified Protein Derivative (PPD) or chest x-ray findings indicative of prior tuberculosis infection
- Any medical condition or treatment that, in the opinion of the investigator, would put the subject at risk by participation in the study
- History of malignancy. More information on this criterion can be found in the protocol.
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
- Investigational biological or chemical agents within 4 weeks prior to randomization.
- History of drug or alcohol abuse within a year prior to randomization
- Treatment with natalizumab, rituximab, or another B-cell depleting therapy within a year prior to randomization
- Treatment with infliximab, abatacept, tocilizumab, golimumab, or certolizumab pegol within 12 weeks prior to randomization.
- Known allergy or hypersensitivity to study products
- Any psychiatric disorder that prevents the participant from providing informed consent
- Inability to follow protocol instructions
- Pregnant or breastfeeding
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00796705
Start Date
November 1 2008
End Date
October 1 2010
Last Update
October 4 2012
Active Locations (16)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Stanford University
Palo Alto, California, United States, 94304
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
4
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239