Phase 4 N=25 Treatment

Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT02321930 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Mar 2019

Primary outcome: Primary: PDUS — 28.68; 19.52; 12.17 units on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: tofacitinib 5mg po bid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY PDUS	28.68; 19.52; 12.17	<0.0001 sig
PRIMARY GSUS	48.44; 44.88; 37.92	<0.0001 sig
PRIMARY CDAI	39.88; 28.60; 21.63	<0.0001 sig
PRIMARY DAS28/ESR	6.26; 5.23; 4.56	<0.0001 sig
SECONDARY MBDA	50.56; 40.96; 39.63	<0.0001 sig

Summary

This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and whether early MSUS measures/MBDA can predict response to therapy.

Eligibility Criteria

Inclusion Criteria

Patient must meet 1987 ACR criteria
Age > 18 years of age
Baseline DAS28/ESR>=3.2
Stable concomitant DMARDs
Stable prednisone =10
Female subjects of childbearing potential must test negative for pregnancy
Male and female subjects of childbearing potential must agree to use contraception throughout the study
Negative QuantiFERON Gold test at screening

Exclusion Criteria

No active TB
Prednisone >10 mg
Pregnancy or breast feeding
Prior treatment with tofacitinib
Concomitant biologic therapy (TNF inhibitors, IL-6 inhibitors, etc.)
Active infection with HIV, hepatitis B or C, or herpes zoster
Subjects with any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities:
Evidence of hematopoietic disorder or hemoglobin 1.5 times the upper limit of normal (x ULN)
Estimated GFR <40 ml/min
Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)
Subjects who require concomitant treatment with medications that are potent inhibitors of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4 and potent inhibitors of CYP2C19, and potent CYP inducers (See Appendix)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02321930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.