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The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00748930
Recruitment Status : Terminated (Challenging data collection)
First Posted : September 9, 2008
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT study. Site investigators will conduct a chart review and complete a data collection form. The purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the ATTRACT trial up until their most recent assessment by the treating physicians.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Other: Retrospective Chart Review and Data collection

Detailed Description:
Subjects were selected for this study using a non-probability sampling method.

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Canadian ATTRACT Follow-up Program
Study Start Date : September 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2007

Group/Cohort Intervention/treatment
Cohort 1
Subjects previously enrolled in the ATTRACT trial from three Canadian sites.
Other: Retrospective Chart Review and Data collection
Retrospective Chart Review and Data collection




Primary Outcome Measures :
  1. To describe the treatment used after completion of the ATTRACT trial in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  2. To describe the long-term therapeutic response as measured by the ACR status in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]

Secondary Outcome Measures :
  1. To describe the long term safety of infliximab in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: Adverse events will be recorded only for the period after completion of the ATTRACT follow-up. ]
  2. Disease Activity Score (DAS) [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  3. Morning stiffness [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  4. Swollen joint count [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  5. Tender joint count [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  6. Rheumatoid factor (RF) presence [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  7. C-reactive Protein (CRP) values [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  8. Erythrocyte Sedimentation Rate (ESR) values [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  9. Annualized X-ray Progression before and after infliximab [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  10. Health Assessment Questionnaire [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  11. Pain Score [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  12. Patient Global Assessment of Disease Status [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  13. Physician Global Assessment of Disease Status [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]
  14. Healthcare Utilization [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously enrolled in the ATTRACT trial from three Canadian sites.
Criteria

Inclusion Criteria:

  • Patients must have been enrolled in the two year follow-up phase of ATTRACT and have continued treatment with the site investigator
  • Signature of informed consent.

Exclusion Criteria:

  • Not specified in the protocol.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00748930     History of Changes
Other Study ID Numbers: P04868
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases