Trial Outcomes & Findings for Baricitinib in Relapsing Giant Cell Arteritis (NCT NCT03026504)

NCT ID: NCT03026504

Last Updated: 2022-04-08

Results Overview

The percentage of subjects who experienced greater than or equal to one adverse event

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2022-04-08

Participant Flow

Participant milestones

Measure	Single Arm All participants assigned to baricitinib 4 mg daily orally for 52 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baricitinib in Relapsing Giant Cell Arteritis

Baseline characteristics by cohort

Measure	Baricitinib Therapy n=15 Participants 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Age, Continuous	72.4 years STANDARD_DEVIATION 7.2 • n=113 Participants
Sex: Female, Male Female	11 Participants n=113 Participants
Sex: Female, Male Male	4 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants
Race (NIH/OMB) White	15 Participants n=113 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	15 participants n=113 Participants
Duration of GCA	9 months n=113 Participants
BMI	26.3 kg/m2 STANDARD_DEVIATION 3.4 • n=113 Participants
Median number of prior GCA relapses	1 events n=113 Participants
Baseline Predinose dose 30 mg/day	4 Participants n=113 Participants
Baseline Predinose dose 20 mg/day	6 Participants n=113 Participants
Baseline Predinose dose 10 mg/day	5 Participants n=113 Participants

PRIMARY outcome

Timeframe: 52 weeks

The percentage of subjects who experienced greater than or equal to one adverse event

Outcome measures

Measure	Baricitinib Therapy n=15 Participants 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Adverse Events	93 percentage of subjects

SECONDARY outcome

Timeframe: 24 weeks, 52 weeks

Population: One subject withdrawn at week 8. Data was not collected or analyzed for week 24 and week 52

The number of subjects to experience relapse of GCA at 24 weeks and 52 weeks. As defined as:

Presence of ESR ≥30 mm/hour and/or CRP ≥10 mg/L and the presence of at least one of the following:

• Unequivocal cranial symptoms of GCA.
• Unequivocal symptoms of PMR.
• Other features judged by the clinician to be consistent with GCA or PMR (eg, fever of unknown origin, unexplained weight loss, fatigue/ malaise, etc) for which no other aetiology was identified as causational.

Outcome measures

Measure	Baricitinib Therapy n=14 Participants 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Giant Cell Arteritis (GCA) Relapse 24 Weeks	1 Participants
Giant Cell Arteritis (GCA) Relapse 52 Weeks	1 Participants

SECONDARY outcome

Timeframe: week 0, week 24, week 52

Population: One subject withdrawn at week 8. Data was not collected or analyzed for week 24 and week 52

ESR is a blood test that detects and monitors inflammation in the body. The normal range is 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.

Outcome measures

Measure	Baricitinib Therapy n=15 Participants 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Erythrocyte Sedimentation Rate (ESR) Week 24	13 mm/hr Interval 7.0 to 19.0
Erythrocyte Sedimentation Rate (ESR) Week 52	10 mm/hr Interval 5.0 to 17.0
Erythrocyte Sedimentation Rate (ESR) Week 0	7 mm/hr Interval 6.0 to 17.0

SECONDARY outcome

Timeframe: week 0, week 24, week 52

Population: One subject withdrawn at week 8. Data was not collected or analyzed for week 24 and week 52. NA indicates CRP levels are \< 3 mg/L, but lab values do not return any actual values that are below this level of detection. Unable to use the "\<" symbol.

C-reactive protein is a substance produced by the liver in response to inflammation. Normal blood CRP levels are below 3.0 mg/L.

Outcome measures

Measure	Baricitinib Therapy n=15 Participants 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
C Reactive Protein (CRP) Week 0	3.4 mg/L Interval to 6.9 N/A indicates CRP levels are \< 3 mg/L, but lab values do not return any actual values that are below this level of detection. Unable to use the "\<" symbol.
C Reactive Protein (CRP) Week 24	NA mg/L N/A indicates CRP levels are \< 3 mg/L, but lab values do not return any actual values that are below this level of detection. Unable to use the "\<" symbol.
C Reactive Protein (CRP) Week 52	NA mg/L Interval to 3.1 N/A indicates CRP levels are \< 3 mg/L, but lab values do not return any actual values that are below this level of detection. Unable to use the "\<" symbol.

Adverse Events

Baricitinib Therapy

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Baricitinib Therapy n=15 participants at risk 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Blood and lymphatic system disorders thrombocytopenia	6.7% 1/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.

Other adverse events

Measure	Baricitinib Therapy n=15 participants at risk 4 milligrams oral Baricitinib daily for 52 weeks Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks
Infections and infestations Infection not requiring antibiotics	53.3% 8/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.
Infections and infestations Infection requiring antibiotics	33.3% 5/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.
Gastrointestinal disorders Nausea	40.0% 6/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.
General disorders Edema limbs - leg	13.3% 2/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.
General disorders Fatigue	13.3% 2/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Adverse events were collected from baseline to end of study, approximately 64 weeks.

Additional Information

Matthew Koster, M.D.

Mayo Clinic

Phone: 507-284-5800

Email: koster.matthew@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place