Arthritis, RheumatoidNCT00748930
The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)
An observational study of Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Retrospective Chart Review and Data collection
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects previously enrolled in the ATTRACT trial from three Canadian sites.
Who may be able to join
- 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.
Who cannot join
- Not specified in the protocol.
About this study
Official title: The Canadian ATTRACT Follow-up Program
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.
Read the detailed description
Subjects were selected for this study using a non-probability sampling method.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Retrospective Chart Review and Data collection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Chart Review and Data collectionOther
Retrospective Chart Review and Data collection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects previously enrolled in the ATTRACT trial from three Canadian sites. Receives: Other: Retrospective Chart Review and Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the treatment used after completion of the ATTRACT trial in patients enrolled as subjects in the ATTRACT trial from Canadian sites.
Measured: 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.
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.
Measured: 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 (14)
To describe the long term safety of infliximab in patients enrolled as subjects in the ATTRACT trial from Canadian sites.
Measured: Adverse events will be recorded only for the period after completion of the ATTRACT follow-up.
Disease Activity Score (DAS)
Measured: 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.
Morning stiffness
Measured: 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.
Swollen joint count
Measured: 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.
Tender joint count
Measured: 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.
Rheumatoid factor (RF) presence
Measured: 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.
C-reactive Protein (CRP) values
Measured: 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.
Erythrocyte Sedimentation Rate (ESR) values
Measured: 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.
Annualized X-ray Progression before and after infliximab
Measured: 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.
Health Assessment Questionnaire
Measured: 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.
Pain Score
Measured: 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.
Patient Global Assessment of Disease Status
Measured: 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.
Physician Global Assessment of Disease Status
Measured: 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.
Healthcare Utilization
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionOct 2006
- Study completionOct 2007
Why it stopped: Challenging data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748930
- Sponsor's protocol ID
- P04868
- Status last verified
- Feb 2015
- First submitted
- 5 Sep 2008
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian ATTRACT Follow-up Program
- ClinicalTrials.gov ID
- NCT00748930
- Acronym / sponsor ID
- P04868
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Challenging data collection
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Retrospective Chart Review and Data collectionSubjects previously enrolled in the ATTRACT trial from three Canadian sites. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects previously enrolled in the ATTRACT trial from three Canadian sites.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not specified in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Chart Review and Data collectionRetrospective Chart Review and Data collection | Other | Cohort 1 |
Primary outcome
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.
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.
14 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Challenging data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Challenging data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.