Status:
COMPLETED
Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States popul...
Detailed Description
RA is characterized by persistent inflammation of peripheral joints, causing pain, stiffness, swelling and warmth. Over the past 10 years, advancements in biotechnology have revolutionized RA therapeu...
Eligibility Criteria
Inclusion
- Diagnosis of RA\*
- Disease duration as defined from the onset of symptoms of at least 3 months prior to study entry
- Active RA with DAS28 \> 4.4, clinically requiring the addition of anti-TNF therapy
- Stable dose of MTX between 7.5 mg and 25 mg weekly for at least 8 weeks prior to study entry
- Able and willing to self-administer subcutaneous injections or have available qualified person(s) or caregiver to administer subcutaneous injections
- For females, agree to use accepted methods of contraception during the duration of the study and for 150 days after study completion\*. \*More information on these criterion can be found in the protocol.
Exclusion
- Positive PPD test - a tuberculosis (TB) skin test: (\> 5 mm induration regardless of prior Bacille Calmette-Guerin \[BCG\] vaccine administration) without evidence of ongoing treatment for at least 30 days or completed treatment
- History of positive PPD or chest x-ray findings indicative of prior TB infection, without documentation of either treatment for TB infection or chemoprophylaxis for TB exposure
- Prednisone dose \> 10 mg/day (or equivalent dose of another corticosteroid) within 30 days prior to study entry
- Definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment\*
- Concomitant use of DMARDSs (e.g., disease-modifying antirheumatic drugs)\*
- Any immunosuppressive therapy other than MTX, NSAIDs, or corticosteroids\*
- Current or previous use of any biologic agent
- Presence of open leg ulcers
- Chronic or persistent infection that might be worsened by immunosuppressive treatment\*
- Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to study entry
- Received oral antibiotics, antivirals, or antifungals within 14 days prior to study entry
- Certain abnormal laboratory values\*
- Any medical condition that, in the opinion of the investigator, would interfere with the study
- History of malignancy other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma within 10 years prior to study entry
- Any Investigational agent within the earlier of 4 weeks or 5 half-lives prior to study entry
- History of drug or alcohol abuse within 6 months prior to study entry
- Known allergy or hypersensitivity to study products
- Inability or unwillingness to follow the protocol
- Any condition or treatment that, in the opinion of the investigator, places the participant at an unacceptable risk
- Pregnant or breastfeeding \*More information on these criterion are in the protocol.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00837434
Start Date
March 1 2009
End Date
January 1 2014
Last Update
September 22 2021
Active Locations (7)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Yale University School Medicine
New Haven, Connecticut, United States, 06519
4
University of Chicago
Chicago, Illinois, United States, 60637