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

Part of paid clinical trials in Aventura, Florida.

Sponsor
Norman B. Gaylis, MD
Study ID
NCT02566967
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • tofacitinib — DRUG
    oral tofacitinib will be taken 2 times daily

Study Details

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

Key Dates

Start date
May 31, 2015
Status verified
Jan 2017
Primary completion
Dec 31, 2017
Completion
Mar 20, 2018

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: open label
    open label use of tofacitinib at either 5 mg bid or 10 mg bid delending on treat to target goal

Primary Outcome Measure

Record the optimal dose of tofacitinib needed to achieve LDA or clinical remission as measured by CDAI score [ Time Frame: one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
AARDS Research, Inc.AventuraFlorida33180-

Find similar trials in Aventura, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
AARDS Research, Inc.· Aventura, FL

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