Multicenter, Randomized, Controlled Placebo Study measuring Effectiveness and Safety of TENOVIL (rHulL-10, SCH 52000) plus a Stable Dose of Methotrexate in Subjects with Active RHEUMATOID Arthritis.
- Conditions
- -M069M069
- Registration Number
- PER-043-99
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Man or woman of at least 18 years of age.
• Diagnosis of RA that matches the criteria of the American College of Rheumatology (ACR), for at least 6 months prior to entering the study (see Appendix C).
• Inadequate response to MTX of 12.5-25 mg / week (unless there is documented toxicity in which doses of> 10 mg / week have been used), as the active RA is defined according to the ACR criteria.
• Active RA is defined as: six or more tender joints, six or more swollen joints, and at least one of the following two points:
• duration of morning stiffness equal to or greater than 45 minutes, or rate of
• erythrocyte sedimentation equal to or greater than 28 mm / hr® ^ or a protein C reagent equal to or greater than 20 mg / l.
• Functional Classes 1, 11 or III
• Willingness to participate in this study and complete all follow-up evaluations. Women of childbearing age will agree to practice adequate birth control measures during and at least one month after treatment with TENOVIL.
• Ability to give written informed consent.
• Read and understand your native language.
• All subjects may be receiving stable therapy with a non-DMARD antirheumatic medication, at least one month before entering the study. These medications may include non-steroidal anti-inflammatory agents (NSAIDs) or salicylates or low oral doses of corticosteroids.
• Doses and scheduling of all antirheumatic agents should remain unchanged throughout the study. Some subjects may have been treated with oral prednisone or its equivalent (<10 mg / day) as long as the subject has been on a stable dose basis for at least one month before entering the study.
• An Independent Blind Evaluator will evaluate the counts of sensitive and inflamed joints
• All subjects must be receiving concomitant metrotrexate therapy as follows:
• Treatment at least 4 months before entering the study (oral or parenteral)
• Stable dosage during the last two months with 12.5 to 25 mg / week (oral or parenteral) unless there is documented toxicity and doses as low as 10 mg / week can be used.
• The route of administration (oral, parenteral) should not change at least 2 months before entering the study and throughout the study.
• In case of documented MTX toxicity, the dose of MTX can be reduced to> 10 mg / week.
• All subjects should be under stable dose of folic acid (minimum 1 mg / day or 5 mg / week) or folinic acid (minimum 5 mg / week) at least one month before entering the study and throughout the period of the study.
• All subjects must have left all other DMARDs (hydroxychloroquine, cyclosporine, azathioprine, sulfasalazine, gold salts, and penicillamine-D) for a period of at least 4 weeks prior to the administration of the study drug.
• Women of childbearing age who do not use an effective method of birth control, pregnant women or lactating women.
• Any subject who has received other drugs in experimentation (including biological agents) during the previous 3 months.
• Any subject who has received ARA VA in the previous 3 months, but who has not received therapy with cholestyramine or any subject who has received ARAVA in the previous 6 months.
• Any subject who has received anti-TNF therapy in the last 3 months.
• Severe physical disability or clinical evidence of ankylosis of the joints or functional Class IV.
• Hemoglobin <9.0 g / dl; WBC <3.5 x 10® / i; platelets <100 x 109 / l; LFT> 2 times above the normal limit; creatinine> 150 umol / l or 1.8 mg / dl.
• History of cancer: treatment of neoplasia in the last five years, except basal cells or squamous cell carcinoma of the skin or cervical carcinoma In situ. Duke A colorectal carcinoma is allowed, if cured with resection, more than five years previously.
• A positive test for double-stranded DNA antibodies or a history of systemic lupus erythematosus, or signs and symptoms suggestive of systemic lupus erythematosus.
• History of clinically significant opportunistic infection in the three months prior to admission.
• Subjects with a clinically significant neurological condition that could interfere with the subjects´ compliance with the requirements of the protocol or with the researcher´s interpretation of the study´s findings (for example: active Parkinson´s disease, attacks in the last 5 years, take anti-crisis medication, active immune mediated diseases such as MS).
• Subjects with any clinically significant disease (apart from defined active RA) that could interfere with the subjects´ compliance with the requirements of the protocol or with the researcher´s interpretation of the findings of! study.
• Subjects who have had osteomyelitis or infection in the joints in the last 6 months.
• History of prosthetic infection in the joints if you still have the prosthesis.
• Subjects with known abuse of substances, including alcohol abuse.
• Pre-treatment with TENOVIL.
• Severe adverse events due to MTX or inability to tolerate a stable regimen of at least 10 mg / week.
• Use of injected asteroids (IM, IV, intra-articular, epidural) for one month before admission.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The response rate based on the ACR criterion 20. The other variables, which are key to efficacy and identified by the Committee for Owners of Medicinal Products (CPMP), will be (1) the percentage of subjects that achieve an improvement of> 20% in the number of inflamed joints, (2) the percentage of subjects that achieve an improvement of> 20% in the number of sensitive joints and (3) the percentage of subjects that achieve an improvement of> 20% in physical functioning (Index of Standard Disability or SDI score) after 12 weeks of study.<br>Measure:Efficacy<br>Timepoints:After 12 and 26 weeks of study.<br>
- Secondary Outcome Measures
Name Time Method