None listed
Conditions
Interventions
Infliximab Type of group
Infliximab 3 mg / kg in intravenous infusion administered at weeks 0, 2, 6 and every 8 weeks until completing 54 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Men and women from> 18 to 45 minutes, C-reactive protein> 2.0 mg / l, ESR> 28 mm / h • Patients must have been using MJX parenterally for at least 2 months without treatment suspensions of more than 2 total weeks during this period. Patients should have been at a stable dose of> 7.5 mg / week (IM, SC, VO) at least 8 weeks before the count. • Men and women of childbearing age should be using appropriate birth control measures (abstinence, oral contraceptives, OID, barrier method with spermicides or surgical sterilization) and should continue with such precautions for six months after receiving the last infusion. • Patients should be receiving folic acid prophylaxis at a stable dose at least 4 weeks prior to screening. • Patients who use oral corticosteroids or NSAIDs should have been receiving a stable dose at least 4 weeks before the screening, and should continue during the treatment period. If currently neither corticosteroids nor NSAIDs are being used, the patient You must not have been receiving corticosteroids or NSAIDs at least 4 weeks before the screening. • Patients must be able to comply with the visit schedule and other protocol requirements. • Patients must be able to give their informed consent and consent must have been obtained before any screening procedure.
Exclusion criteria
Exclusion criteria: • Pregnant women, breastfeeding mothers or a pregnancy planned in a year and a half since admission. • Patients who are incapacitated, who must remain in bed for long periods or totally or who are confined to a wheelchair and who have little or no ability to care for themselves. • Patients who have any current systemic inflammatory condition with signs and symptoms that may confuse evaluations of the benefit of therapy with INFLIXIMAB, e.g., Lyme disease, or a rheumatic disease independent of rheumatoid arthritis. • The use of DMARDs independently of MTX during the 4 weeks prior to scrutiny. • Use of intra-articular corticosteroids, IM or IV (including ACTH) during the 4 weeks prior to the scrutiny. • Treatment with any drug in research for 1 month prior. • 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 infections of the upper respiratory system (colds) or uncomplicated infections of the urinary system that need to be considered as exclusions at the discretion of the treating doctor. • History of opportunistic infections such as herpes zoster in the last 2 months. from the scrutiny. Evidence of active CMV, active pneumocystis carinii, atypical mycobacteria resistant to drugs, etc. • HIV infection documented. • Current signs and symptoms of severe, progressive or uncontrolled, renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral conditions. • Any currently known neoplasm or pre-neoplastic lesions or any history of neoplasia in the last five years. • Patients with alcoholism, liver disease due to alcoholism, or other chronic liver diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The clinical response to treatment will be defined by the criteria for improvement of the ACR (> 20% reduction in the number of inflamed and painful joints and> 20% improvement in three of the following: evaluation of pain by the patient, evaluation of the activity of the disease by the patient or the researcher, disability assessment and PCR. Measure:Achieve the ACR improvement criteria at week 30 Timepoints:Week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Response evaluations to assess treatment efficacy will include: joint assessment, morning stiffness, pain, fatigue, Measure:Drugs ability to reduce signs and symptoms, reduce disability, delay joint damage Timepoints:Week 54 ; Outcome name:X-rays of hands and feet will be taken before treatment, and in weeks 30 and 54. Measure:Drugs capacity to produce remission of the disease Timepoints:Weeks 30 and 54 | — |
Countries
Peru
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed