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Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00794898
First received: November 19, 2008
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
This is an open-label program of Remicade in the treatment of patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy of infliximab.

Condition Intervention Phase
Arthritis, Rheumatoid Biological: Infliximab (Remicade) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ]

Enrollment: 19
Actual Study Start Date: July 1, 2003
Study Completion Date: April 1, 2004
Primary Completion Date: April 1, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Remicade in the treatment of patients with active RA despite treatment with MTX.
Biological: Infliximab (Remicade)
Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6. All patients will continue to receive the same dose of MTX they were receiving at entry throughout the subsequent treatment period.
Other Names:
  • Remicade
  • SCH 215596

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00794898     History of Changes
Other Study ID Numbers: P03027
Study First Received: November 19, 2008
Last Updated: March 27, 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 22, 2017