18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PDUSPrimary· Baseline, Week 2, Month 3
30 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.
Baseline
Group
Value
95% CI
Tofacitinib 5mg po Bid
28.68
± 17.75
Week 2
Group
Value
95% CI
Tofacitinib 5mg po Bid
19.52
± 15.38
Week 12
Group
Value
95% CI
Tofacitinib 5mg po Bid
12.17
± 10.64
GSUSPrimary· Baseline, Week 2, Month 3
30 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level.
Baseline
Group
Value
95% CI
Tofacitinib 5mg po Bid
48.44
± 16.53
Week 2
Group
Value
95% CI
Tofacitinib 5mg po Bid
44.88
± 16.36
Week 12
Group
Value
95% CI
Tofacitinib 5mg po Bid
37.92
± 15.32
CDAIPrimary· Baseline, Week 2, Month 3
CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate
Baseline
Group
Value
95% CI
Tofacitinib 5mg po Bid
39.88
± 13.21
Week 2
Group
Value
95% CI
Tofacitinib 5mg po Bid
28.60
± 13.23
Week 12
Group
Value
95% CI
Tofacitinib 5mg po Bid
21.63
± 13.02
DAS28/ESRPrimary· Baseline, Week 2, Month 3
TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. Patient Global Assessment of disease activity was scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. ESR lab value were included in the total calculation. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation.The scale ranges from 0 to 9.4, where higher values represent a higher d
Baseline
Group
Value
95% CI
Tofacitinib 5mg po Bid
6.26
± 1.19
Week 2
Group
Value
95% CI
Tofacitinib 5mg po Bid
5.23
± 1.31
Week 12
Group
Value
95% CI
Tofacitinib 5mg po Bid
4.56
± 1.36
MBDASecondary· Baseline, Week 2, Month 3
The multi-biomarker disease activity (MBDA) blood test assesses RA disease activity. An algorithm of 12 markers is used to characterize RA disease activity on a scale of 1-100, where a score of 100 represents the highest level of disease activity present.
Baseline
Group
Value
95% CI
Tofacitinib 5mg po Bid
50.56
± 17.50
Week 2
Group
Value
95% CI
Tofacitinib 5mg po Bid
40.96
± 15.10
Week 12
Group
Value
95% CI
Tofacitinib 5mg po Bid
39.63
± 15.28
Adverse events — posted to ClinicalTrials.gov
Time frame: 1.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
· recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel
· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
Last refreshed: 19 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02321930.