52-Week Extension Study to Evaluate the Safety, Tolerability and Maintenance of the Clinical Effects of MK-0966 in Rheumatoid Arthritis in Patients Who Completed 1 Year of Pivotal Efficacy Tests.

Not Applicable

• Conditions: -M069; M069

• Registration Number: PER-042-00
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-07-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• The patient was registered in Protocol 097 of MK-0966.
• The patient met all the original inclusion criteria for the base study (Protocol 097)
• The patient completed the base study. Parts I and n through Visit 12.0 (52 weeks in the treatment of the protocol).
• The patient tolerated the study-based medication and, in the opinion of the investigator and clinical monitor, demonstrated that he had completed the study procedures and the study medication.
• The patient understands the study procedures and agrees to participate in the extension study by signing the informed consent.

Exclusion Criteria

• The patient experienced and / or was discontinued from study therapy due to serious or clinically important or serious adverse experiences during the baseline study.
• Any specific contraindication to chronic naproxen therapy
• The patient will need any of the following concomitant medications: Warfarin, Ticlopidine, Misoprostol, NSAIDs corresponding to the study, Chronic corticosteroid therapy greater than the equivalent of 10 mg daily of prednisone, aspirin in low doses that exceed 81 mg / day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Adverse events will be recorded in each exam on the Adverse Event Case Report Forms.<br>Measure:Safety<br>Timepoints:During the whole study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Global Patient Assessment of Pain (VAS)<br>Global Assessment of the Patient on the Activity of the Disease (VAS)<br>Global Researchers Assessment of Disease Activity (Likert)<br>Health Assessment Questionnaire (HAQ)<br>Measure:Efficacy<br>Timepoints:The Likert and VAS scale will be recorded in Visits 14.0 to 18.0 and in the discontinuation visit (if the patient discontinues the study).<br>The patient will respond to the Stanford Health Assessment Questionnaire (HAQ) on Visits 16.0 and 18.0 (or the discontinuation visit).<br>