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This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be determined at the same time period by the use of the OMERACT/RAMRIS scoring system
This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be determined at the same time period by the use of the OMERACT/RAMRIS scoring system and correlated to the clinical findings. The target for each patient will be determined at the time of study entry depending on the degree of disease activity of the individual patient. This is based on the understanding that LDA is an acceptable goal in certain patients with long standing disease or high disease activity. If the patient reaches LDA while taking tofacitinib at a 5 mg b.i.d. dose, the patient will be given the opportunity to have the dose increased to 10 mg b.i.d. in the hopes of reaching clinical remission.
There are two treat to target goals: Clinical Remission as defined by a CDAI score of <2.8 for those patients who entered the study with a CDAI score of <22 and Low Disease Activity (LDA) as defined by a CDAI score of <10 for those who entered the study with a CDAI score of > 22.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Other | open label use of tofacitinib at either 5 mg bid or 10 mg bid delending on treat to target goal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib | Drug | oral tofacitinib will be taken 2 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Record the optimal dose of tofacitinib needed to achieve LDA or clinical remission as measured by CDAI score | the daily dosed used in patients to achieve LDA | one year |
| Measure | Description | Time Frame |
|---|---|---|
| low -field (0.3T) MRI will be used to measure the reduction of synovitis and bone edema | was synovitis, bone edema and erosion reduced | one year |
| correlation of the structural and clinical responses performed the structural outcomes as measured by MERERACT and correlate them to the clinical responses and dose adjustments made during the course of the study |
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Inclusion Criteria:
Exclusion Criteria:
the following approved biological therapy for RA: etanercept, adalimumab, anakinra, abatacept, tocilizumab within 28 days of baseline
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AARDS Research, Inc. | Aventura | Florida | 33180 | United States |
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was there a correlation is structural and clinical response |
| one year |
| record the number of patients who reach low disease activity and a measurable structural response | the number of patient who reached LDA and a measurable structural change | one year |
| record the number of patients in which structural response occurred without clinical response | number of patients who had a structural response but no clinical response | one year |
| record the number of patients who required an increase in the dose of tofacitinib due to lack of clinical response from Baseline as measured by CDAI score | number of patients who had dose escalated to 10 mg bid | one year |
| record the change in CDAI score for all patients from Baseline through the last dose of the initial dose (5 mg b.i.d) of tofacitinib | record CDAI scores from Baseline to Week 52 | one year |
| record the change in CDAI score from the step up period ( 10 mg b.i.d) to the end of the dosing period | record CDAI score at dose 10 mg bid | one year |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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