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Completed

NCT Number: NCT00264147

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etoricoxib

Drug

Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.

Comparator: placebo

Drug

Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.

Comparator: diclofenac

Drug

Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2005
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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