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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02566967
• Date of registration: 01/10/2015
• Prospective Registration: No
• Primary sponsor: Norman B. Gaylis, MD
• Public 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
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02566967
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient must be at least 18 years old at the screening visit

2. Patient must be able to understand the information provided to them and give written
Informed Consent

3. Female subjects of childbearing potential must test negative for pregnancy

4. Male and female subjects of childbearing potential must agree to use two highly
effective methods of contraception throughout the study and for at least 3 months
after the last dose of tofacitinib.

5. Female patients who are not of childbearing potential must either be postmenopausal
for at least 12 months or have undergone a documented hysterectomy and/or bilateral
oophorectomy.

6. Patients can be naïve to biologic therapy or have had exposure to TNF or biologic
therapy (see appropriate wash out schedule) and be experiencing at least a moderate
disease activity score as determined by a CDAI of > 10 at Screening despite currently
receiving Methotrexate therapy at a dose of 10-25 mg/weekly for at least 12 weeks and
at a stable dose for the past 4 weeks.

7. Patients on prednisone must be receiving a daily dose of < 10 mg.

8. Subjects must screen negative for active tuberculosis (TB) by either a PPD or a
QuantiFERON Gold test (unless previously performed and documented within 3 months
prior to screening). If patient tests positive for latent TB at screening, the chest
X-ray at Screening must be negative for active TB and the patient must be started on (
or have completed) an adequate course of therapy for latent tuberculosis at the
Baseline visit. Patient must complete the entire 9 month course of treatment for
latent TB.

9. Chest radiograph taken at screening (unless taken and documented within 3 months prior
to screening) must be negative for active TB and have non clinically significant
medical findings.

10. Patients must be able and willing to comply with the requirements of the study
protocol

Exclusion Criteria:

1. Patients who have a history of any inflammatory disease which would be interfere with
outcome measurement

2. Patients who in the Investigator's opinion have a medical condition in which
participation in this trial is contraindicated

3. Patients who have received intramuscular, intravenous, or intraarticular (IM/IV/IA)
corticosteroids 28 days prior to baseline.

4. Patients who have active TB or a history of active TB (positive PPD skin test >5mm and
a positive chest x-Ray) or patients who have come in close contact with an individual
with active TB.

5. Patients with a history of acute or chronic viral hepatitis B or C or those who test
positive at screening.

6. Patients with a known human immunodeficiency virus (HIV) infection.

7. Concurrent malignancy or a history of malignancy other than a non-metastatic basal
cell or squamous cell cancer of the skin or cervical carcinoma in situ.

8. Patients who have a metal device affected by MRI (e.g. any type of electronic,
mechanical or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted
cardioverter defibrillator; or cochlear implant)

9. Patients who have potential ferromagnetic foreign body (metal slivers metal shavings,
other metal objects) for which they have sought medical attention

10. Patients at a high risk of infection in the Investigator's opinion or have had
recurrent infections requiring hospitalization or parenteral antimicrobial therapy
within the past 6 months.

11. Patients with an adverse reaction to tofacitinib

12. Patients with any other condition (e.g., clinically significant laboratory values)
which in the Investigator's judgment would make the patient unsuitable for inclusion
in this study

13. Patients who have received prohibited medications:

the following approved biological therapy for RA: etanercept, adalimumab, anakinra,
abatacept, tocilizumab within 28 days of baseline

- rituximab within 9 months of baseline

- infliximab within 56 days of baseline

- DMARDs other than methotrexate within 28 days of baseline

- any experimental biologic agent within three months or 5 half-lives prior to baseline

- exposure to JAK inhibitor 14. Female patients who are breast-feeding, pregnant, or
plan to become pregnant during the trial or within twelve weeks following last dose of
study drug



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: tofacitinib

Primary Outcome(s)

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

Secondary Outcome(s)

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 [Time Frame: 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 [Time Frame: one year]

record the number of patients who reach low disease activity and a measurable structural response [Time Frame: 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 [Time Frame: one year]

low -field (0.3T) MRI will be used to measure the reduction of synovitis and bone edema [Time Frame: one year]

record the number of patients in which structural response occurred without clinical response [Time Frame: 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 [Time Frame: one year]

Secondary ID(s)

RA-012015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors