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A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00202852
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Other: Placebo Drug: MTX Biological: Infliximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate
Actual Study Start Date : June 1, 2005
Actual Primary Completion Date : March 1, 2006
Actual Study Completion Date : March 1, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Other: Placebo
Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX

Drug: MTX
Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week

Experimental: 2 Biological: Infliximab
Infliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
Other Names:
  • Remicade
  • SCH 215596

Drug: MTX
3 mg/kg infliximab infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week




Primary Outcome Measures :
  1. Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. [ Time Frame: 30-week follow-up visit. ]

Secondary Outcome Measures :
  1. Safety evaluations will include measurements of vital signs during and immediately after the infusions of study agents. [ Time Frame: During and immediately after the infusions of study agents. ]
  2. Assessment of adverse events at each of the evaluation visits. [ Time Frame: At each evaluation visit. ]
  3. Routine, laboratory tests (hematology, blood chemistry, and urinalysis) will be performed at Screening, at 2 and 6 weeks, and thereafter every 8 weeks through Week 30 for patients. [ Time Frame: At Screening, Week 2, Week 6, and then every 8 weeks thereafter through Week 30. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Active disease at the time of screening and pre-infusion as defined by:

    • >=6 swollen joints
    • >=6 tender joints and 2 of the following:

      • morning stiffness >=45 min
      • ESR >=28 mm/h
      • CRP >=20 mg/L
  • Men and women, >=18 to <=75 years of age
  • 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 have been using oral or parenteral MTX for at least 3 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 >=12.5 mg/wk (maximum 20mg/wk) for at least 4 weeks prior to screening.
  • Patients must be on a stable dose of folic acid prophylaxis for at least 4 weeks prior to screening.
  • Patients using oral corticosteroids, must have been on a stable dose of <=10 mg/day for at least 4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for at least 4 weeks prior to screening.
  • If using NSAIDs, patients should have been on a stable dose for at least 4 weeks prior to screening. If currently not using NSAIDs the patient must have been off for at least 4 weeks prior to screening.
  • The screening laboratory tests must meet the following criteria:

    • Hemoglobin >=5.3 mmol/L (>=8.5 g/dL), providing a low hemoglobin level is not due to nutritional deficiencies or due to diseases other than chronic RA
    • WBC >=3.5 x 10^9/L
    • Neutrophils >=1.5 x 10^9/L
    • Platelets >=100 x 10^9/L
    • Serum transaminase <=2 times the upper limit of normal
    • Alkaline phosphatase levels <=2 times the upper limit of normal
    • Serum creatinine <=150 µmol/L (<=1.7 mg/dL)
  • Patient must be able to adhere to the study visit schedule and other protocol requirements.
  • Patient must be capable of giving informed consent and the consent must have been obtained prior to any study procedures including wash-out period.

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 Infliximab therapy, eg Lyme disease, or a rheumatic disease other than RA.
  • Use of DMARDs other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.)
  • Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening.
  • Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab).
  • Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months.
  • Treatment with any investigational drug within the previous 3 months.
  • Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.
  • Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.
  • History of infected joint prosthesis within previous 5 years.
  • Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
  • Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis.
  • Have active TB. Also excluded are patients who have evidence of latent TB (positive PPD skin test or a history of latent TB) without adequate therapy for TB initiated prior to first infusion of study drug. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the trial. Patients with a current close contact with an individual with active TB will also be excluded. Additionally, patients who have completed treatment for active TB within the previous 2 years are now explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc, within the previous 6 months.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
  • History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.
  • Any current known malignancy or history of malignancy within the previous 5 years, except for squamous or basal cell carcinoma of the skin that have been treated with no evidence of recurrence.
  • Patients with moderate or severe heart failure (NYHA class III/IV)
  • Patients with pre-existing or recent onset of central nervous system demyelinating disorders
  • Known recent substance abuse (drug or alcohol).
  • Patients in whom multiple venipunctures are not feasible due to poor tolerability or lack of easy access.
  • Have a known infection with HIV or known active hepatitis B/C infection (including associated chronic active hepatitis).

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00202852     History of Changes
Other Study ID Numbers: P04280
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 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