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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264147
First Posted: December 12, 2005
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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.


Enrollment: 761
Study Start Date: January 2006
Study Completion Date: March 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00264147     History of Changes
Other Study ID Numbers: 0663-086
2005_077
First Submitted: December 9, 2005
First Posted: December 12, 2005
Results First Submitted: March 19, 2009
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