A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2004-004302-24-IT
• Lead Sponsor: MERCK SHARP DOHME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-11-21
• Study Start: 2007-08-10
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) Dimostrare l’efficacia clinica di L-000883191 1,25mg due volte al giorno nel trattamento dell’artrite reumatoide (AR) durante 12 settimane di trattamento. (2) Dimostrare la sicurezza e la tollerabilita' di L-000883191 in pazienti con AR. <br>;Secondary Objective: ;Primary end point(s):