NCT00542022

Brief Summary

To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

October 5, 2007

Last Update Submit

October 19, 2015

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count

    12 weeks

Secondary Outcomes (1)

  • MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients

    12 weeks

Interventions

MK0812 / Duration of Treatment: 12 WeeksDRUG
Comparator: placebo (unspecified) / Duration of Treatment: 12 WeeksDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
  • Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
  • Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

You may not qualify if:

  • Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
  • Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
  • Female patient is pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Duration of Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

October 5, 2007

First Posted

October 10, 2007

Study Start

June 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

October 20, 2015

Record last verified: 2015-10