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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00317538
Date of registration: 21/04/2006
Prospective Registration: No
Primary sponsor: Centocor Ortho Biotech Services, L.L.C.
Public title: Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept
Scientific title: Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept
Date of first enrolment: June 2003
Target sample size: 28
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Affiliation:  Centocor Ortho Biotech Services, L.L.C.
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

- 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: infliximab, etanercept
Primary Outcome(s)
Evaluate safety and evidence of therapeutic benefit of infliximab and methotrexate, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), at week 16
Secondary Outcome(s)
Evaluate pharmacokinetics, immunogenicity, structural damage and pharmacodynamics over the study period
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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