Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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 of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Adalimumab; Etanercept

Criteria

Inclusion Criteria:

• 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:

1. Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly.

2. Leflunomide - maximum dose of 20 mg PO daily.

3. Sulfasalazine - maximum dose of 1,500 mg PO twice daily.

4. 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 Criteria:

• 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