Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-02-10 @ 11:48 AM
Study NCT ID:
NCT02566967
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2015-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective
Sponsor:
Norman B. Gaylis, MD
Organization:
Study Overview
Official Title:
An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: