Clinical trial NCT00748930: The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)
Official title: The Canadian ATTRACT Follow-up Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously enrolled in the ATTRACT trial from three Canadian sites.

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.

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

Eligibility 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.

Primary outcomes:
measure: To describe the treatment used after completion of the ATTRACT trial in patients enrolled as subjects in the ATTRACT trial from Canadian sites.
timeFrame: 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.
measure: 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.
timeFrame: 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 outcomes:
measure: To describe the long term safety of infliximab in patients enrolled as subjects in the ATTRACT trial from Canadian sites.
timeFrame: Adverse events will be recorded only for the period after completion of the ATTRACT follow-up.
measure: Disease Activity Score (DAS)
timeFrame: 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.
measure: Morning stiffness
timeFrame: 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.
measure: Swollen joint count
timeFrame: 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.
measure: Tender joint count
timeFrame: 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.
measure: Rheumatoid factor (RF) presence
timeFrame: 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.
measure: C-reactive Protein (CRP) values
timeFrame: 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.
measure: Erythrocyte Sedimentation Rate (ESR) values
timeFrame: 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.
measure: Annualized X-ray Progression before and after infliximab
timeFrame: 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.
measure: Health Assessment Questionnaire
timeFrame: 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.
measure: Pain Score
timeFrame: 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.
measure: Patient Global Assessment of Disease Status
timeFrame: 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.
measure: Physician Global Assessment of Disease Status
timeFrame: 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.
measure: Healthcare Utilization
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References: