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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264147
• Other study ID #: 0663-086
• Secondary ID: 2005_077
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• etoricoxib
Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
• etoricoxib
Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
• etoricoxib
Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
• etoricoxib
Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
• Comparator: placebo
Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
• etoricoxib
Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
• Comparator: diclofenac
Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.	Time-weighted average change from baseline across Weeks 2, 7, and 12
Secondary	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.	Time-weighted average change from baseline across Weeks 2, 7, and 12
Secondary	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.	Time-weighted average change from baseline across Weeks 2, 7, and 12