A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01208181
First received: September 22, 2010
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: May 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Etoricoxib 60 mg
Drug: Etoricoxib 90 mg
Drug: Placebo to Etoricoxib 60 mg
Drug: Placebo to Etoricoxib 90 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Etoricoxib 60 mg The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
Etoricoxib 90 mg The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
Etoricoxib 60 mg/Etoricoxib 60 mg The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
Etoricoxib 60/Etoricoxib 90mg The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
Placebo The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.

Participant Flow for 2 periods

Period 1:   Part 1
    Etoricoxib 60 mg     Etoricoxib 90 mg     Etoricoxib 60 mg/Etoricoxib 60 mg     Etoricoxib 60/Etoricoxib 90mg     Placebo  
STARTED     818     468     0     0     118  
COMPLETED     719 [1]   413 [2]   0     0     96 [2]
NOT COMPLETED     99     55     0     0     22  
Withdrawal by Subject                 11                 10                 0                 0                 0  
Technical problem                 5                 0                 0                 0                 0  
Protocol Violation                 10                 5                 0                 0                 0  
Physician Decision                 4                 0                 0                 0                 0  
Non-compliance with study drug                 1                 1                 0                 0                 0  
Lost to Follow-up                 5                 3                 0                 0                 1  
Lack of Efficacy                 37                 12                 0                 0                 17  
Adverse Event                 26                 24                 0                 0                 4  
[1] Six participants from this arm did not continue into Part II of the study
[2] Per protocol, participants in this arm did not continue into Part II of the study

Period 2:   Part 2
    Etoricoxib 60 mg     Etoricoxib 90 mg     Etoricoxib 60 mg/Etoricoxib 60 mg     Etoricoxib 60/Etoricoxib 90mg     Placebo  
STARTED     0 [1]   0 [1]   350 [2]   363 [3]   0 [4]
COMPLETED     0     0     334     343     0  
NOT COMPLETED     0     0     16     20     0  
Adverse Event                 0                 0                 6                 7                 0  
Withdrawal by Subject                 0                 0                 1                 1                 0  
Protocol Violation                 0                 0                 1                 0                 0  
Physician Decision                 0                 0                 1                 2                 0  
Non-compliance with study drug                 0                 0                 1                 1                 0  
Lost to Follow-up                 0                 0                 1                 2                 0  
Lack of Efficacy                 0                 0                 5                 7                 0  
[1] Per protocol, there were no participants in this arm during Part II of the study
[2] Participants receiving etoricoxib 60 mg in Part I received etoricoxib 60 mg in Part II of the study
[3] Participants receiving etoricoxib 60 mg in Part I received etoricoxib 90 mg in Part II of the study
[4] Per protocol, participants did not receive placebo during Part II of the study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Etoricoxib 60 mg The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
Etoricoxib 90 mg The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
Placebo The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
Total Total of all reporting groups

Baseline Measures
    Etoricoxib 60 mg     Etoricoxib 90 mg     Placebo     Total  
Number of Participants  
[units: participants]
  818     468     118     1404  
Age  
[units: Years]
Mean (Standard Deviation)
  53.8  (11.9)     54.0  (12.3)     53.6  (11.0)     53.8  (12.0)  
Gender  
[units: Participants]
       
Female     677     395     100     1172  
Male     141     73     18     232  
Disease Activity Score using C reactive protein (DAS28-CRP) [1]
[units: Scores on a scale]
Mean (Standard Deviation)
  5.64  (0.99)     5.62  (1.00)     5.65  (1.12)     5.63  (1.00)  
Patient Global Assessment of Pain [2]
[units: Scores on a scale]
Mean (Standard Deviation)
  70.84  (15.50)     70.58  (15.02)     74.08  (14.23)     71.02  (15.24)  
[1] The DAS28-CRP index (0 - 10 Range) is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. (N = 732, 426, 103 for Etoricoxib 60 mg, Etoricoxib 90 mg, and Placebo).
[2] A participant overall assessment of pain on a visual analog scale (VAS) were assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). (N = 751, 430, 108 for Etoricoxib 60 mg, Etoricoxib 90 mg, and Placebo)



  Outcome Measures
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1.  Primary:   Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)   [ Time Frame: Baseline and Week 6 ]

2.  Primary:   Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:   Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1   [ Time Frame: Week 6 and Week 10 to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01208181     History of Changes
Other Study ID Numbers: 0663-107, 2010-019871-31
Study First Received: September 22, 2010
Results First Received: May 5, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration