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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00794898
Date of registration: 19/11/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)
Scientific title: Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
Date of first enrolment: July 1, 2003
Target sample size: 19
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00794898
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women, >=18 to <=75 years of age.

- Diagnosis of RA according to the revised 1987 criteria of the American Rheumatism
Association (Arnett et al., 1988). The disease should have been diagnosed at least 6
months prior to Screening.

- Patients have active disease, in the opinion of the physician, despite the concomitant
use of DMARDS. Evidence of active disease may include any of the following:

6 or more swollen or tender joints; and 2 of the following

- Morning stiffness >45 minutes

- C-reactive protein >2.0 mg/L

- ESR >28 mm/h

- Patients must have been using oral or parenteral MTX for at least 2 months with no
break(s) in treatment of more than 2 weeks total during this period. Patients must
have been on a stable dose of >=7.5 mg/wk (IM, SQ, PO) for at least 8 weeks prior to
Screening.

- Men and women of childbearing potential must be using adequate birth control measures
(abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical
sterilization) and should continue such precautions for 6 months after receiving the
last infusion.

- Patients must be on a stable dose of folic acid prophylaxis for at least 4 weeks prior
to Screening.

- Patients using oral corticosteroids or NSAIDs, must have been on a stable dose for at
least 4 weeks prior to Screening, and must continue during the treatment period. If
currently not using corticosteroids or NSAIDs, the patient must have not received
corticosteroids or NASIDs for at least 4 weeks prior to Screening.

- Patients must be able to adhere to the program visit schedule and other protocol
requirements.

- Patients must be capable of giving informed consent and the consent must have been
obtained prior to any screening procedures.

Exclusion Criteria:

- Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment

- Patients who are incapacitated, largely or wholly bedridden or confined to a
wheelchair, and who have little or no ability for self-care.

- Patients who have any current systemic inflammatory condition with signs and symptoms
that might confound the evaluations of benefit from the Remicade therapy, eg, Lyme
disease, or a rheumatic disease other than RA.

- Use of DMARDS other than MTX within 4 weeks prior to Screening.

- Use of intra-articular, IM, or IV. corticosteroids (including IM ACTH) within 4 weeks
prior to Screening.

- Prior administration any other therapeutic agent targeted at reducing TNF (eg,
Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 6
months.

- Treatment with any investigational drug within the previous 6 months.

- A history of known allergies to murine proteins.

- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3
months. Less serious infections in the previous 3 months, such as acute upper
respiratory tract infection (colds) or uncomplicated urinary tract infection need not
be considered exclusions at the discretion of the treating physician.

- History of opportunistic infections such as herpes zoster within 2 months of
Screening. Evidence of active CMV, active pneumocystis carinii, drug resistant
atypical mycobacterium, etc.

- Documented HIV infection.

- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.

- Any currently known malignancy or pre-malignant lesions or any history of malignancy
within the past 5 years.

- Patients with alcoholism, alcoholic liver disease, or other chronic liver disease.

- Patients with a positive PPD within 3 months and chest X-Ray suggestive of active TB
or a previous exposure to TB.

- Patients with CHF, even if asymptomatic or not requiring medication must be excluded.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Biological: Infliximab (Remicade)
Primary Outcome(s)
Define the onset of efficacy of infliximab in patients with active RA, using the validated SF-36 questionnaire. [Time Frame: After the first 2 weeks of treatment.]
Secondary Outcome(s)
Secondary ID(s)
P03027
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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