Phase 4
Completed N=25
Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT02321930 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Mar 2019
Primary outcomePrimary: PDUS — 28.68; 19.52; 12.17 units on a scale — p=<0.0001
◆ Published Evidence
Established
28citations · ~5 / year
Ultrasound and multi-biomarker disease activity score for assessing and predicting clinical response to tofacitinib treatment in patients with rheumatoid arthritis.
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.
Linked Publications (3)
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Ultrasound and multi-biomarker disease activity score for assessing and predicting clinical response to tofacitinib treatment in patients with rheumatoid arthritis.
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The beneficial effect of baricitinib on ultrasound-detected synovial inflammation and bone damage in rheumatoid arthritis: Preliminarily data from single center-based observational study for 24 weeks.
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Ultrasound detects synovitis in replaced and other surgically operated joints in rheumatoid arthritis patients.
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 |
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)
Data sourced from ClinicalTrials.gov (NCT02321930) and the linked publication. 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. Informational only — not medical advice.