Trial record 8 of 34 for:
Open Studies | "Arthritis, Psoriatic"
Biologic Rheumatology Registry Across Canada (BioTRAC)
This study is currently recruiting participants.
Verified May 2013 by Janssen Inc.
Sponsor:
Janssen Inc.
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects being treated with infliximab and golimumab for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA). In contrast to a controlled clinical trial, there is no imposed experimental intervention and the subjects' physicians solely will determine the subject's treatment. Thus, the data captured and reported in this registry will reflect a "real world" approach to treatment with infliximab or golimumab.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA) Rheumatology (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis) |
Resource links provided by NLM:
Further study details as provided by Janssen Inc.:
Primary Outcome Measures:
- Disease status of Canadian subjects treated with infliximab or golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of subjects with adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Expanded information and support for healthcare providers and hospitals about the appropriate use of infliximab and golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Subjects will be selected for this registry using a non-probability sampling method.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants with RA, AS, or PsA will be selected primarily from community centers and some academic centers.
Criteria
Inclusion Criteria:
- Participant is starting infliximab or golimumab at the time of enrollment or has been treated with one other prior biologic (including infliximab and golimumab) within the 6 months prior to enrollment
- Participant has been diagnosed with RA, AS or PsA and is eligible for treatment with infliximab or golimumab as per the Product Monograph
Exclusion Criteria:
- Participant was treated with any biologic, for any period of time, prior to 6 months before enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741793
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Janssen Inc.
Investigators
| Study Director: | Janssen Inc. Clinical Trial | Janssen Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Inc. |
| ClinicalTrials.gov Identifier: | NCT00741793 History of Changes |
| Other Study ID Numbers: | CR100762, P02843 |
| Study First Received: | August 22, 2008 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Janssen Inc.:
|
Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis Remicade® Simponi® registry BioTRAC |
Additional relevant MeSH terms:
|
Arthritis, Psoriatic Arthritis Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis |
ClinicalTrials.gov processed this record on May 16, 2013