- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794898
Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)
March 27, 2017 updated by: Merck Sharp & Dohme LLC
Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Remicade in the treatment of patients with active RA despite treatment with MTX.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
After the first 2 weeks of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2003
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
November 19, 2008
First Submitted That Met QC Criteria
November 19, 2008
First Posted (Estimate)
November 20, 2008
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P03027
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis, Rheumatoid
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on Infliximab (Remicade)
-
Merck Sharp & Dohme LLCCentocor, Inc.CompletedCrohn's Disease
-
BiocadCompletedAnkylosing SpondylitisRussian Federation, Belarus
-
Merck Sharp & Dohme LLCCentocor, Inc.Completed
-
Centocor, Inc.Centocor BVCompletedArthritis, Rheumatoid | Psoriasis | Crohn DiseaseUnited States, Canada, France, Germany, Poland, United Kingdom, Belgium, Spain, Argentina, Israel, Switzerland, Finland, Sweden, Netherlands, Austria, Hungary, Ireland, Norway, Denmark
-
Xiaomin ZhangActive, not recruitingUveitis | Infliximab
-
Egla C. RabinovichChildhood Arthritis and Rheumatology Research AllianceCompletedChronic UveitisUnited States
-
Peking Union Medical College HospitalChanghai Hospital; West China Hospital; Shenzhen People's Hospital; First People... and other collaboratorsUnknownRheumatoid Arthritis | Ultrasonography | InfliximabChina
-
Center for Integrated Rehabilitation and Organ...Centocor, Inc.Completed
-
James Chodosh, MD, MPHMassachusetts Eye and Ear Infirmary; Fonds de recherche en ophtalmologie de...WithdrawnStevens-Johnson Syndrome | Mucous Membrane Pemphigoid | Toxic Epidermal Necrolysis (Lyell) SyndromeUnited States, Canada
-
Gu JieruoCompleted