Rheumatoid Arthritis Clinical Trial
Official title:
Treating to Target (T2T) for Patients With Rheumatoid Arthritis in a US Population: Outcomes and Feasibility
NCT number | NCT01407419 |
Other study ID # | NEIRB 11-216 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | July 2014 |
Verified date | June 2015 |
Source | Corrona, LLC. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data Collection Program) sites. Subjects are recruited to participate in this 12 month trial examining outcomes and feasibility of implementing a Treat to Target approach, when compared with a control group of subjects treated with usual care.
Status | Completed |
Enrollment | 538 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients eligible for the study will be both male and female adult (at least 18 years of age) patients who have a documented diagnosis of RA, are enrolled or willing to be enrolled in the CORRONA registry for the duration of the trial, have signed appropriate informed consent documents, are willing to participate in the trial, are medically appropriate for participation in the opinion of the investigator, and have moderate to severe RA disease activity as defined by CDAI >10. Exclusion Criteria: 1. Patients under the age of 18 2. Women who are pregnant, breastfeeding or planning to become pregnant during the study period. 3. Patients with chronic or acute pain condition(s) other than active RA which, in the opinion of the investigator, is likely to confound or interfere with assessments of RA disease activity. 4. Functional class IV as defined by the ACR classification of functional status 5. Patients receiving a daily dose of prednisone of >10 mg within the 4 weeks prior to enrollment. 6. History of positive tuberculin skin test or equivalents that have not received documented treatment for latent tuberculosis (TB). 7. Patients with a significant, uncontrolled concomitant illness such as, but not limited to cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic, pulmonary or lymphatic disease. |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Rheumatology | Albany | New York |
Lead Sponsor | Collaborator |
---|---|
Corrona, LLC. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Activity, probability of treatment acceleration conditional on disease activity. | CDAI Score, rates of acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity. | 1 year | |
Secondary | Disease activity scores, reasons for ineligibility for treatment acceleration, frequency of toxicity, frequency of TAEs. | CDAI scores, DAS 28, RAPID 3, reasons/frequency of ineligibility for treatment acceleration, frequency of suspected (RA) drug-related toxicity, frequency of TAEs | 1 year |
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