A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0873
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MK-0873
Placebo
Arm Description
MK-0873 1.25 mg twice daily for 12 weeks
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132769
Brief Title
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-0873
Arm Type
Experimental
Arm Description
MK-0873 1.25 mg twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
MK-0873
Intervention Description
MK-0873 1.25 mg twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Swollen Joint Count
Description
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.
Time Frame
Baseline and the average of Treatment Weeks 8, 10 and 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
Description
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.
Time Frame
Baseline and the average of Treatment Weeks 8, 10 and 12
Title
Change From Baseline in Tender Joint Count
Description
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.
Time Frame
Baseline and the average of Treatment Weeks 8, 10 and 12
Title
Patient Global Assessment of Disease Activity
Description
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.
Time Frame
The average of Treatment Weeks 8, 10 and 12
Title
Investigator Global Assessment of Disease Activity
Description
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.
Time Frame
Treatment Week 12
Title
Patient Global Assessment of Response to Therapy
Description
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.
Time Frame
Treatment Week 12
Title
Health Assessment Questionnaire Disability Index
Description
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.
Time Frame
The average of Treatment Weeks 8, 10 and 12
Title
Patient's Assessment of Pain
Description
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.
Time Frame
Treatment Week 12
Title
Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein
Description
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.
Time Frame
Baseline and the average of Treatment Weeks 8, 10 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
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A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
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