A Second extension study to assess the safety, tolerabillty and mantenance of clinical efTects of iVlK-0663 in rheumatoid artritis patients
- Conditions
- -M069M069
- Registration Number
- PER-056-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a.The patient was enrolled in Protocol 010-00 of MK-0663 and in the first extension. b.The patient fulfilled all the original inclusion criteria for Protocol 010-00 and the first extension. c. The patient completed Protocol 010-00 and the first extension until Visit 17.0 (104 weeks with the protocol treatment). d.The patient tolerated the study medication and, in the opinion of the researcher and the clinical monitor, demonstrated that he had complied with the study procedures and medication. e.The patient understands the study procedures and agrees to participate in the study by signing the informed consent. f.At Visit 19.0, patients of childbearing age must demonstrate that they have a level of P-HCG in urine that is consistent with a non-pregnant state and must agree to abstain or use the double barrier contraception method.
a.The patient had and / or was withdrawn from study therapy due to serious or clinically important adverse experiences during Protocol 010-00 or the first extension. b.Some specific contraindication to permanent therapy with diclofenac. c. c. The patient will require any of the following concomitant medications: Warfarin, Misoprostol, Sucralfate, Digoxin, Ticlopidine, Clopidogrel, Aspirin (> 100 mg / day), Some ACME or specific COX-2 inhibitor that is not included in the study, Permanent therapy with corticosteroids in an amount greater than the equivalent of 10 mg daily of prednisone, continuous use (any period greater than 6 consecutive days) of H2 blockers (cimetidine, ranitidine, famotidine, nizatidine), antacids, or proton pump inhibitors in doses Prescribed or in doses without medical prescription.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Physical examination, vital signs, weight, blood biochemistry, blood cell count, urinalysis, electrocardiogram and P-HCG in urine.<br>Measure:Safety<br>Timepoints:During the control visits and at the end of the study.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The assessment of pain by the patient, the evaluation of the disease activity on the part of the patient and the global evaluation of the activity of the disease by the researcher. Discontinuations caused by lack of efficacy will serve as a secondary endpoint. Patients will respond to the HAQ disability scales<br>Measure:Efficacy<br>Timepoints:Health Assessment Questionnaire in Weeks 34 and 70 of the Second Extension (Visits 21.0 and 23.0).<br>