A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)

NCT00132769 | Completed Phase 2 Results

• 2 other identifiers: 0873-0122005_029
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Swollen Joint Count

  Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.

  Baseline and the average of Treatment Weeks 8, 10 and 12

Secondary Outcomes (8)

• Percentage of Participants With American College of Rheumatology 20% Response [ACR20]

  Baseline and the average of Treatment Weeks 8, 10 and 12

• Change From Baseline in Tender Joint Count

  Baseline and the average of Treatment Weeks 8, 10 and 12

• Patient Global Assessment of Disease Activity

  The average of Treatment Weeks 8, 10 and 12

• Investigator Global Assessment of Disease Activity

  Treatment Week 12

• Patient Global Assessment of Response to Therapy

  Treatment Week 12

Study Arms (2)

MK-0873

EXPERIMENTAL

MK-0873 1.25 mg twice daily for 12 weeks

Drug: MK-0873

Placebo

PLACEBO COMPARATOR

Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

Drug: Comparator: Placebo

Interventions

MK-0873 DRUG

MK-0873 1.25 mg twice daily for 12 weeks

MK-0873

Comparator: Placebo DRUG

Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
• Other criteria also apply

You may not qualify if:

• Other major illnesses
• Past history of certain other disorders
• Certain prohibited medications

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MK 0873

Condition Hierarchy (Ancestors)

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

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: August 2, 2005
• First Posted: August 22, 2005
• Study Start: January 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: July 30, 2015
• Results First Posted: February 3, 2014

Record last verified: 2015-07