Status:
COMPLETED
Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of therapeutic benefit o...
Detailed Description
Therapeutic agents designed to bind and block the biological activities of tumor necrosis factor-alpha (TNFa) have been shown to be effective in the treatment of rheumatoid arthritis (RA). Two anti-TN...
Eligibility Criteria
Inclusion
- Patients have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association
- Have been receiving background MTX for at least 2 months prior to week -4
- Have been receiving a stable etanercept dose of 25 mg subcutaneously twice weekly for at least 2 months prior to week -4
- Must have been using oral or parenteral MTX for the 2 months prior to screening and at a stable dose of 7.5 to 25 mg per week between week -4 and week 0
- Have shown improvement in signs and symptoms of RA in response to etanercept and MTX according to both the patient and the treating physician
- Have active disease as defined by both a TJC of at least 9 (on the 68 joint set) and SJC of at least 6 (on the 66 joint set)
- Have a documented negative reaction to a purified protein derivative (PPD) skin test (PPD induration\< 5 mm) performed within 3 months prior to the week 0 visit
Exclusion
- Patients have been receiving corticosteroids (ie, via any route) at doses \> 10 mg prednisone equivalent daily or have not been taking a stable dose of corticosteroids for at least 1 month prior to week -4
- Have started receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 month of week -4 or have not been on a stable dose of NSAIDs for at least 1 month prior to week -4
- Have received disease modifying anti-rheumatic drugs (DMARDs) or immunosuppressives (except MTX) for at least 1 month prior to week 0
- Patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing TNF, except etanercept, (e.g.pentoxifylline or thalidomide)
- Patients with a concomitant diagnosis of Congestive Heart Failure, including medically controlled asymptomatic patients
- Any current known malignancy or history of malignancy within the previous 5 years
- Serious infection within the past 3 months or history of chronic infection such as hepatitis, pneumonia, or pyelonephritis in the previous 3 months, any opportunistic infections
- known substance abuse (drug or alcohol) within the previous 3 years
- Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00317538
Start Date
June 1 2003
End Date
November 1 2004
Last Update
May 19 2011
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