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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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 ]

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 ]
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 ]
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 ]

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
Period I: 1: Experimental etoricoxib	Drug: etoricoxib Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
Period I: 2: Experimental etoricoxib	Drug: etoricoxib Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
Period I: 3: Experimental etoricoxib	Drug: etoricoxib Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
Period I: 4: Experimental etoricoxib	Drug: etoricoxib Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Period I: 5: Placebo Comparator Placebo	Drug: Comparator: placebo Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
Period II: 1: Experimental etoricoxib	Drug: etoricoxib Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Period II: 2: Active Comparator 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_077, MK0663-086
Study First Received:	December 9, 2005
Results First Received:	March 19, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00264147 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Etoricoxib
Arthritis, Rheumatoid
Diclofenac
Enzyme Inhibitors
Rheumatic Diseases

Pharmacologic Actions
Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010