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: August 22, 2014
Last verified: August 2014

September 22, 2010
August 22, 2014
September 2010
June 2014   (final data collection date for primary outcome measure)
  • Time-Weighted Average Change From Baseline in DAS28-CRP in Part I (etoricoxib vs. placebo) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part I [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Part I: Proportion of American College of Rheumatology-20 (ACR20) responders: 90 mg vs. placebo; and 60 mg vs placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The proportion of participants who meet the ACR20 criteria for response at completion of Part I will be compared among participants who received 60 mg or 90 mg Etoricoxib, and placebo. ACR20 response is defined as an improvement of >/= 20% from baseline a 20 in tender or swollen joint counts, as well as 20 percent improvement in three of five other criteria.
  • Part I: Time-weighted average change from baseline in participant Global Assessment of Pain via visual analog scale (VAS): 90 mg Etoricoxib vs. placebo; and 60 mg Etoricoxib vs. placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The time-weighted average change from baseline in VAS scores, over 6 weeks, will be compared among participants who received 60 mg and 90 mg Etoricoxib, and placebo. The VAS is a 100mm scale with 0 = 'no pain' and 100 = 'extreme pain'. The participant indicates their current pain level by placing a mark along the scale.
Complete list of historical versions of study NCT01208181 on ClinicalTrials.gov Archive Site
  • Time-Weighted Average Change From Baseline in DAS28-CRP in Part I (etoricoxib 90 mg vs. etoricoxib 60 mg) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Time-Weighted Mean Change From Baseline in Patient Global Assessment of Pain in Part I (etoricoxib 90 mg vs. etoricoxib 60 mg) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Average change from Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 Among Pain Inadequate Responders [ Time Frame: Week 6 and Week 10, Week 12 ] [ Designated as safety issue: No ]
  • Part I: Proportion of ACR20 Responders: 90 mg vs. 60 mg Etoricoxib [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The proportion of participants who meet the ACR20 criteria for response at completion of Part I of the study will be compared between participants who received 60 mg and 90 mg Etoricoxib
  • Part I: Time-weighted average change from baseline in VAS scores: 90 mg vs. 60 mg Etoricoxib [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The time weighted average change from baseline in VAS scores over 6 weeks will be compared between participants who received 60 mg and 90 mg etoricoxib
  • Part II: Average change from Week 6 in participant Global Assessment of Pain over Weeks 10 and 12: compared for 60/90 mg Etoricoxib vs. 60/60 mg Etoricoxib, among pain non-responders from Part I [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The incremental benefit of increasing the Etoricoxib dose from 60 mg in Part I to 90 mg in Part II, compared to those remaining on 60 mg in Part II will be assessed using the VAS for the participant Global Assessment of Pain among participants who are non-responders during Part I
  • Part II: Proportion of ACR20 Responders: 60/90 mg Etoricoxib vs. 60/60 mg Etoricoxib [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The incremental benefit of increasing the Etoricoxib dose from 60 mg in Part I to 90 mg in Part II, compared to those remaining on 60 mg in Part II will be assessed by using the average change from baseline over weeks 10 and 12 for the individual components of the ACR 20 criteria among participants who are non-responders during Part I.
  • Part I: Time-weighted average change from baseline in participant Global Response to Therapy scores: 90 mg Etoricoxib vs. placebo; 60 mg Etoricoxib vs. placebo; and 90 mg vs. 60 mg Etoricoxib [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The time weighted average change from baseline in participant Global Response to Therapy scores over 6 weeks will be compared between the 3 treatment groups: 90 mg Etoricoxib vs. placebo; 60 mg Etoricoxib vs. placebo; and 90 mg vs. 60 mg Etoricoxib. participant Global Response to Therapy is scored on a 0 to 4 scale 0 = 'very well' to 4 = 'very poor'
  • The Proportion participants who discontinue due to lack of efficacy in Part I [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Proportion participants who discontinue due to lack of efficacy in Part I will be compared among the 3 treatment groups: 90 mg Etoricoxib vs. placebo; 60 mg Etoricoxib vs. placebo; and 90 mg vs. 60 mg Etoricoxib.
  • Average change from Week 6 in participant Global Response to Therapy over Weeks 10 and 12: 60 mg/90mg vs. 60 mg/90 mg etoricoxib among pain non-responders [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Part II: Average change from Week 6 in participant Global Response to Therapy over Weeks 10 and 12: 90 mg vs. 60 mg, and 60 mg vs. 60 mg, among pain non-responders from Part I
Not Provided
Not Provided
 
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK‑0663/Etoricoxib in Patients With Rheumatoid Arthritis

This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain from baseline over 6 weeks of treatment. Additionally the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Etoricoxib 60 mg
    One tablet orally once daily for 6 weeks.
    Other Name: MK-0663
  • Drug: Etoricoxib 90 mg
    One tablet orally once daily for 6 weeks.
    Other Name: MK-0663
  • Drug: Placebo to Etoricoxib 60 mg
    One tablet orally once daily for 6 weeks.
  • Drug: Placebo to Etoricoxib 90 mg
    One tablet orally once daily for 6 weeks
  • Experimental: Etoricoxib 60 mg/Etoricoxib 60 mg
    The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
    Interventions:
    • Drug: Etoricoxib 60 mg
    • Drug: Placebo to Etoricoxib 60 mg
  • Experimental: Etoricoxib 60 mg/Etoricoxib 90 mg
    The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part I and etoricoxib 90 mg tablets administered orally once daily in Part 2 of the study.
    Interventions:
    • Drug: Etoricoxib 60 mg
    • Drug: Placebo to Etoricoxib 60 mg
  • Experimental: Etoricoxib 90 mg
    The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily in Part 1 and will not participate in Part 2 of the study.
    Interventions:
    • Drug: Etoricoxib 90 mg
    • Drug: Placebo to Etoricoxib 90 mg
  • Placebo Comparator: Placebo
    The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily in Part 1 and will not participate in Part 2 of the study.
    Interventions:
    • Drug: Placebo to Etoricoxib 60 mg
    • Drug: Placebo to Etoricoxib 90 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1404
August 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is male or female ≥ 18 years of age in general good health (other than RA)
  • Has an ACR Functional Class I, II, or III
  • Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed
  • Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study

Exclusion Criteria:

  • Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
  • Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption
  • Has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
  • Has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease
  • Class II-IV congestive heart failure
  • Has uncontrolled hypertension (systolic >160 mm Hg or diastolic > 90 mm Hg) at Visit 1 or Visit 2
  • Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥5
  • Has estimated glomerular filtration rate ≤30 mL/min
  • Has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix)
  • Is allergic to etoricoxib; history of a significant clinical or laboratory adverse experience associated with etoricoxib; hypersensitivity to aspirin or NSAIDs; or allergy to acetaminophen/paracetamol
  • Has a personal or family history of an inherited or acquired bleeding disorder
  • Requires oral corticosteroid therapy in excess of the equivalent of 10 mg daily of prednisone and/or have not been on a stable dose for at least 4 weeks prior to Visit 1 and/or whose dose is not expected to remain stable during the study
  • Treated with B-cell depleting therapies within the past 6 months or anticipate this treatment during this trial
  • Is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence;
  • Is morbidly obese (defined as body mass index ≥40 kg/m^2)
  • Is pregnant or breast feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01208181
0663-107
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP