Rheumatoid Arthritis Dose Ranging Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00264147

Purpose

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: etoricoxib Drug: Comparator: placebo Drug: Comparator: diclofenac	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Etoricoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of Patients Who Met the ACR20 Responder Index Criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)

Secondary Outcome Measures:

Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) [ Time Frame: Time-weighted average change from baseline across Weeks 2, 7, and 12 ] [ Designated as safety issue: No ]
Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) [ Time Frame: Time-weighted average change from baseline across Weeks 2, 7, and 12 ] [ Designated as safety issue: No ]
Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) [ Time Frame: Time-weighted average change from baseline across Weeks 2, 7, and 12 ] [ Designated as safety issue: No ]
0-mm indicates very well, 100-mm indicates very poor.
Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) [ Time Frame: Time-weighted average change from baseline across Weeks 2, 7, and 12 ] [ Designated as safety issue: No ]
0 indicates very well, 4 indicates very poor.
Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) [ Time Frame: Time-weighted average change from baseline across Weeks 2, 7, and 12 ] [ Designated as safety issue: No ]
0-mm indicates very well, 100-mm indicates very poor.

Enrollment:	761
Study Start Date:	December 2005
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Period I: 1 etoricoxib	Drug: etoricoxib Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
Experimental: Period I: 2 etoricoxib	Drug: etoricoxib Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
Experimental: Period I: 3 etoricoxib	Drug: etoricoxib Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
Experimental: Period I: 4 etoricoxib	Drug: etoricoxib Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Placebo Comparator: Period I: 5 Placebo	Drug: Comparator: placebo Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
Experimental: Period II: 1 etoricoxib	Drug: etoricoxib Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Active Comparator: Period II: 2 diclofenac	Drug: Comparator: diclofenac Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms
Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time

Exclusion Criteria:

Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264147

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00264147 History of Changes
Other Study ID Numbers:	2005_077, MK0663-086
Study First Received:	December 9, 2005
Results First Received:	March 19, 2009
Last Updated:	April 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012