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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
etoricoxib
etoricoxib
etoricoxib
etoricoxib
Comparator: placebo
etoricoxib
Comparator: diclofenac
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arcoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Active Comparator

    Arm Label

    Period I: 1

    Period I: 2

    Period I: 3

    Period I: 4

    Period I: 5

    Period II: 1

    Period II: 2

    Arm Description

    etoricoxib

    etoricoxib

    etoricoxib

    etoricoxib

    Placebo

    etoricoxib

    diclofenac

    Outcomes

    Primary Outcome Measures

    Proportion of Patients Who Met the ACR20 Responder Index Criteria
    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)
    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)
    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)
    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)
    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)
    0-mm indicates very well, 100-mm indicates very poor.

    Full Information

    First Posted
    December 9, 2005
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00264147
    Brief Title
    Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Arcoxia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    761 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Period I: 1
    Arm Type
    Experimental
    Arm Description
    etoricoxib
    Arm Title
    Period I: 2
    Arm Type
    Experimental
    Arm Description
    etoricoxib
    Arm Title
    Period I: 3
    Arm Type
    Experimental
    Arm Description
    etoricoxib
    Arm Title
    Period I: 4
    Arm Type
    Experimental
    Arm Description
    etoricoxib
    Arm Title
    Period I: 5
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    Period II: 1
    Arm Type
    Experimental
    Arm Description
    etoricoxib
    Arm Title
    Period II: 2
    Arm Type
    Active Comparator
    Arm Description
    diclofenac
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: diclofenac
    Intervention Description
    Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
    Primary Outcome Measure Information:
    Title
    Proportion of Patients Who Met the ACR20 Responder Index Criteria
    Description
    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)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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)
    Description
    0-mm indicates very well, 100-mm indicates very poor.
    Time Frame
    Time-weighted average change from baseline across Weeks 2, 7, and 12
    Title
    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)
    Description
    0 indicates very well, 4 indicates very poor.
    Time Frame
    Time-weighted average change from baseline across Weeks 2, 7, and 12
    Title
    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)
    Description
    0-mm indicates very well, 100-mm indicates very poor.
    Time Frame
    Time-weighted average change from baseline across Weeks 2, 7, and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21905970
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25886874
    Citation
    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.
    Results Reference
    derived

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

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