CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Baricitinibdrug
Likely dose
Baricitinib 4 mg orally once dailyAI-extracted
Key inclusion· 6
  • ✓Age ≥50 years
  • ✓History of ESR ≥50 mm/hr or CRP ≥10 mg/L
  • ✓At least one cranial symptom of GCA (new headache, scalp/temporal artery tenderness, jaw pain) OR PMR symptoms (shoulder/hip girdle pain with inflammatory stiffness) OR systemic symptoms (fever >38°C ≥7 days, weight loss, night sweats)
  • ✓Temporal artery biopsy showing GCA OR imaging evidence of large-vessel vasculitis (MRA, CTA, PET-CT, or ultrasound)
Key exclusion· 15
  • ✕Presence of any other autoimmune disease (SLE, rheumatoid arthritis, other vasculitides, scleroderma, polymyositis, dermatomyositis)
  • ✕Symptoms of visual loss (transient or permanent blindness) or diplopia attributable to GCA
  • ✕History of aortic dissection, myocardial infarction, or cerebrovascular attack attributable to GCA
  • ✕Any live virus vaccination (except herpes zoster) within 3 months before, during, or 3 months after study drug; herpes zoster vaccine must occur >4 weeks prior to randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03026504
NCT03026504Phase 2Completed
CompareCT.gov

Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study

Matthew J Koster·interventional·Posted Jan 20, 2017·Updated Apr 8, 2022

In Brief

A Phase 2 clinical trial evaluating Baricitinib for Arteritis, Giant Cell. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This study will evaluate the safety and effectiveness of baricitinib in the treatment of giant cell arteritis. All participants will be taking prednisone at the start of the study. The prednisone will be reduced according to a standardized tapering schedule while participants continue to take one tablet of baricitinib daily for 52 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArteritis, Giant Cell
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 20, 2017
Enrollment StartMar 9, 2017
Primary CompletionApr 12, 2021
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.5 years ago

Interventions

Baricitinibdrug

4 milligrams oral Baricitinib daily for 52 weeks