Efficacy, Tolerability and Safety Study… | Clinical Trial

Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

Exclusion criteria

Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
Female patient is pregnant or breast-feeding

Treatment and study plan

MK0812 / Duration of Treatment: 12 Weeks

Drug

Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks

Drug

Primary outcomes

MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count

Time frame: 12 weeks

Secondary outcomes

MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Oct 10, 2007
Registry last updated: Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed