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

NCT00264147 | Completed Phase 2 Results

• 2 other identifiers: 0663-0862005_077
• Study Type: interventional
• Target: 761
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (5)

• 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-weighted average change from baseline across Weeks 2, 7, and 12

• 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-weighted average change from baseline across Weeks 2, 7, and 12

• 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-weighted average change from baseline across Weeks 2, 7, and 12

• 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-weighted average change from baseline across Weeks 2, 7, and 12

• 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-weighted average change from baseline across Weeks 2, 7, and 12

Study Arms (7)

Period I: 1

EXPERIMENTAL

etoricoxib

Drug: etoricoxib

Period I: 2

EXPERIMENTAL

etoricoxib

Drug: etoricoxib

Period I: 3

EXPERIMENTAL

etoricoxib

Drug: etoricoxib

Period I: 4

EXPERIMENTAL

etoricoxib

Drug: etoricoxib

Period I: 5

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo

Period II: 1

EXPERIMENTAL

etoricoxib

Drug: etoricoxib

Period II: 2

ACTIVE COMPARATOR

diclofenac

Drug: Comparator: diclofenac

Interventions

etoricoxib DRUG

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

Period I: 1

Comparator: placebo DRUG

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

Period I: 5

Comparator: diclofenac DRUG

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

Period II: 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• 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.

  PMID: 21905970 RESULT

• 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.

  PMID: 25886874 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: July 7, 2009

Record last verified: 2022-02