Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00264147

Recruitment Status : Completed

First Posted : December 12, 2005

Results First Posted : July 7, 2009

Last Update Posted : February 16, 2015

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: etoricoxib Drug: Comparator: placebo Drug: Comparator: diclofenac	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	761 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	January 2006
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

Proportion of Patients Who Met the ACR20 Responder Index Criteria [ Time Frame: 12 weeks ]
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 ]
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 ]
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 ]
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 ]
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 ]
0-mm indicates very well, 100-mm indicates very poor.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264147

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications of Results:

Greenwald M, Peloso PM, Mandel D, Soto O, Mehta A, Frontera N, Boice JA, Zhan XJ, Curtis SP. Further assessment of the clinically effective dose range of etoricoxib: a randomized, double-blinded, placebo-controlled trial in rheumatoid arthritis. Curr Med Res Opin. 2011 Oct;27(10):2033-42. doi: 10.1185/03007995.2011.614935. Epub 2011 Sep 12.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kvien TK, Greenwald M, Peloso PM, Wang H, Mehta A, Gammaitoni A. Do COX-2 inhibitors provide additional pain relief and anti-inflammatory effects in patients with rheumatoid arthritis who are on biological disease-modifying anti-rheumatic drugs and/or corticosteroids? Post-hoc analyses from a randomized clinical trial with etoricoxib. BMC Musculoskelet Disord. 2015 Feb 13;16:26. doi: 10.1186/s12891-015-0468-7.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00264147 History of Changes
Other Study ID Numbers:	0663-086 2005_077
First Posted:	December 12, 2005 Key Record Dates
Results First Posted:	July 7, 2009
Last Update Posted:	February 16, 2015
Last Verified:	January 2015

Keywords provided by Merck Sharp & Dohme Corp.:


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 Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors

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