A Second extension study to assess the safety, tolerabillty and mantenance of clinical efTects of iVlK-0663 in rheumatoid artritis patients

Not Applicable

Completed

• Conditions: -M069; M069

• Registration Number: PER-056-00
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-06
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

a.The patient had and / or was withdrawn from study therapy due to serious or clinically important adverse experiences during Protocol 010-00 or the first extension.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