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

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132769
• Other study ID #: 0873-012
• Secondary ID: 2005_029
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: July 29, 2015
• Start date: January 2005
• Est. completion date: November 2005

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

• Other criteria also apply

Exclusion Criteria:

• Other major illnesses

• Past history of certain other disorders

• Certain prohibited medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MK-0873
MK-0873 1.25 mg twice daily for 12 weeks
• Comparator: Placebo
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With American College of Rheumatology 20% Response [ACR20]	Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.	Baseline and the average of Treatment Weeks 8, 10 and 12	No
Secondary	Change From Baseline in Tender Joint Count	Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.	Baseline and the average of Treatment Weeks 8, 10 and 12	No
Secondary	Patient Global Assessment of Disease Activity	At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: "Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing." The VAS ranges from "Very Well" (0) to "Very Poor" (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity.	The average of Treatment Weeks 8, 10 and 12	No
Secondary	Investigator Global Assessment of Disease Activity	At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.	Treatment Week 12	No
Secondary	Patient Global Assessment of Response to Therapy	Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.	Treatment Week 12	No
Secondary	Health Assessment Questionnaire Disability Index	The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.	The average of Treatment Weeks 8, 10 and 12	No
Secondary	Patient's Assessment of Pain	At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from "No pain" (0) to "Extreme pain" (100). A lower score indicates less pain.	Treatment Week 12	No
Secondary	Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein	C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.	Baseline and the average of Treatment Weeks 8, 10 and 12	No