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

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ClinicalTrials.gov Identifier: NCT00132769
Recruitment Status : Completed
First Posted : August 22, 2005
Results First Posted : February 3, 2014
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MK-0873 Drug: Comparator: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MK-0873
MK-0873 1.25 mg twice daily for 12 weeks
Drug: MK-0873
MK-0873 1.25 mg twice daily for 12 weeks

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




Primary Outcome Measures :
  1. Change From Baseline in Swollen Joint Count [ Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12 ]
    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 :
  1. Percentage of Participants With American College of Rheumatology 20% Response [ACR20] [ Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12 ]
    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.

  2. Change From Baseline in Tender Joint Count [ Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12 ]
    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.

  3. Patient Global Assessment of Disease Activity [ Time Frame: The average of Treatment Weeks 8, 10 and 12 ]
    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.

  4. Investigator Global Assessment of Disease Activity [ Time Frame: Treatment Week 12 ]
    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.

  5. Patient Global Assessment of Response to Therapy [ Time Frame: Treatment Week 12 ]
    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.

  6. Health Assessment Questionnaire Disability Index [ Time Frame: The average of Treatment Weeks 8, 10 and 12 ]
    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.

  7. Patient's Assessment of Pain [ Time Frame: Treatment Week 12 ]
    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.

  8. Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein [ Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132769


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00132769     History of Changes
Other Study ID Numbers: 0873-012
2005_029 ( Other Identifier: Telerex Study Number )
First Posted: August 22, 2005    Key Record Dates
Results First Posted: February 3, 2014
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
MK 0873
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action