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

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01208181
First received: September 22, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Etoricoxib 60 mg
Drug: Etoricoxib 90 mg
Drug: Placebo to Etoricoxib 60 mg
Drug: Placebo to Etoricoxib 90 mg
Phase 3

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
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1250
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Etoricoxib 60 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.
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.
Drug: Etoricoxib 60 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.
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.
Drug: Etoricoxib 90 mg
One tablet orally once daily for 6 weeks.
Other Name: MK-0663
Drug: Placebo to Etoricoxib 90 mg
One tablet orally once daily for 6 weeks
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208181

Contacts
Contact: Toll Free Number 1-888-577-8839

  Hide Study Locations
Locations
United States, Alabama
Call for Information (Investigational Site 0306) Recruiting
Huntsville, Alabama, United States, 35801
United States, Arkansas
Call for Information (Investigational Site 0319) Recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Call for Information (Investigational Site 0317) Recruiting
Encino, California, United States, 91436
Call for Information (Investigational Site 0322) Recruiting
Lomita, California, United States, 90717
Call for Information (Investigational Site 0029) Recruiting
Upland, California, United States, 91786
United States, Florida
Call for Information (Investigational Site 0050) Recruiting
Jacksonville, Florida, United States, 32216
Call for Information (Investigational Site 0324) Recruiting
Lake Worth, Florida, United States, 33464
Call for Information (Investigational Site 0315) Recruiting
Plant City, Florida, United States, 33563
Call for Information (Investigational Site 0026) Recruiting
Summerfield, Florida, United States, 34491
Call for Information (Investigational Site 0316) Recruiting
Winter Haven, Florida, United States, 33880
United States, Indiana
Call for Information (Investigational Site 0311) Recruiting
Evansville, Indiana, United States, 47714
Call for Information (Investigational Site 0310) Recruiting
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Call for Information (Investigational Site 0309) Recruiting
Elizabethtown, Kentucky, United States, 42701
United States, Louisiana
Call for Information (Investigational Site 0308) Recruiting
Monroe, Louisiana, United States, 71203
United States, Massachusetts
Call for Information (Investigational Site 0007) Recruiting
Worcester, Massachusetts, United States, 01610
United States, Mississippi
Call for Information (Investigational Site 0313) Recruiting
Flowood, Mississippi, United States, 39232
United States, New Mexico
Call for Information (Investigational Site 0328) Recruiting
Las Cruces, New Mexico, United States, 88011
United States, New York
Call for Information (Investigational Site 0070) Recruiting
Rochester, New York, United States, 14609
United States, Pennsylvania
Call for Information (Investigational Site 0040) Recruiting
Duncansville, Pennsylvania, United States, 16635
Call for Information (Investigational Site 0320) Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Call for Information (Investigational Site 0012) Recruiting
Dallas, Texas, United States, 75231
Call for Information (Investigational Site 0314) Recruiting
Houston, Texas, United States, 77062
United States, Utah
Call for Information (Investigational Site 0323) Recruiting
West Jordan, Utah, United States, 84068
Argentina
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Czech Republic
Merck Sharp and Dohme s.r.o. Recruiting
Praha, Czech Republic
Contact: Simona Martinkova    420 233010213      
Finland
MSD Finland Oy Recruiting
Espoo, Finland
Contact: Kaisa Elomaa    358 20 7570300      
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Soraya Cedraro    507-282-7200      
India
MSD Pharmaceuticals Pvt. Ltd Recruiting
Mumbai, India
Contact: Viraj Salgaonkar    91 2267892286      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Andrius Bacevicius    370 52780243      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Panama
MSD CARD Recruiting
Panama, Panama
Contact: Soraya Cedraro    507-282-7200      
Peru
Merck Sharp & Dohme, Peru S.R.L. Recruiting
Lima, Peru
Contact: Oscar Espinoza    (51-1) 411-5100      
Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Adam Czernik    48 22 4784324      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Eran Gefen    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Slovakia
Merck Sharp Dohme S.R.O. Recruiting
Bratislava, Slovakia
Contact: Eva Kaszasova    420 233010213      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Taiwan
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Taipei, Taiwan
Contact: Lai Hung Jen    886 2 2730 0030      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01208181     History of Changes
Other Study ID Numbers: 0663-107
Study First Received: September 22, 2010
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014