Baricitinib in Relapsing Giant Cell Arteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03026504
• Date of registration: 17/01/2017
• Prospective Registration: Yes
• Primary sponsor: Matthew J Koster
• Public title: Baricitinib in Relapsing Giant Cell Arteritis
• Scientific title: Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study
• Date of first enrolment: March 9, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03026504
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Kenneth Warrington, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Giant Cell Arteritis (GCA) defined by the following Revised GCA Diagnosis
Criteria:

- Age =50 years.

- History of Erythrocyte Sedimentation Rate (ESR) = 50 mm/hour or C-Reactive
Protein (CRP) = 10 mg/L.

- Presence of at least one of the following:

- Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or
temporal artery tenderness, otherwise unexplained mouth or jaw pain upon
mastication).

- Unequivocal symptoms of Polymyalgia Rheumatica (PMR), defined as shoulder
and/or hip girdle pain associated with inflammatory stiffness.

- Systemic inflammatory disease in which the presence of the fever (>38
degrees Celsius for = 7 days), weight loss (> 5 pounds or 10% premorbid
weight), and/or night sweats were attributable to GCA and no other cause was
identified.

- Presence of at least one of the following:

- Temporal artery biopsy revealing features of GCA.

- Evidence of large-vessel vasculitis by angiography or cross-sectional
imaging, including but not limited to magnetic resonance angiography (MRA),
computed tomography angiography (CTA), positron emission tomography-computed
tomography (PET-CT) or evidence of large-vessel or temporal artery
vasculitis by ultrasound (US).

2. Relapse with active GCA within 6 weeks of study entry where active disease is defined
by an ESR =30 mm/hr or CRP =10 mg/L AND the presence of at least one of the following:

- Unequivocal cranial symptoms of GCA (new onset or recurrent localized headache,
scalp or temporal artery tenderness, otherwise unexplained mouth or jaw pain upon
mastication [i.e., jaw claudication]).

- Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain
associated with inflammatory stiffness.

- Other feature(s) judged by the clinician investigator to be consistent with GCA
or PMR flares (e.g. fever of unknown origin, weight loss, fatigue/malaise, etc.)

3. Clinically stable at baseline visit (study drug initiation) such that the subject is
able to safely participate in the standardized taper regimen in the opinion of the
investigator.

Exclusion Criteria

1. Presence of any other autoimmune disease (such as systemic lupus erythematosus,
rheumatoid arthritis, inflammatory arthritis, other vasculitides, scleroderma,
polymyositis, dermatomyositis, or other similar systemic connective tissue diseases).

2. Subjects demonstrating symptoms of visual loss (transient or permanent blindness) or
diplopia attributable to GCA.

3. Subjects with history of aortic dissection, myocardial infarction, or cerebrovascular
attack attributable to GCA.

4. Has received, or is expected to receive, any live virus vaccinations (with the
exception of herpes zoster vaccination) within 3 months before the first dose of study
drug, during the study, or within 3 months after the last administration of the study
drug. All patients who have not received the herpes zoster vaccine at screening will
be encouraged (per local guidelines) to do so prior to randomization; vaccination must
occur >4 weeks prior to randomization and start of investigational product. Patients
will be excluded if they were exposed to herpes zoster vaccination within 4 weeks of
planned randomization.

5. Organ transplant recipients.

6. Have had a major surgery within 8 weeks prior to screening or will require major
surgery during the study that, in the opinion of the investigator would pose an
unacceptable risk to the patient.

7. Have experienced any of the following within 12 weeks of screening: myocardial
infarction (MI), unstable ischemic heart disease, stroke, or New York Heart
Association Stage IV heart failure

8. Have a history or presence of cardiovascular (including but not limited to
uncontrolled hypertension), respiratory, hepatic, gastrointestinal, endocrine,
hematological, neurological, or neuropsychiatric disorders, or any other serious
and/or unstable illness that, in the opinion of the investigator, could constitute an
unacceptable risk when taking investigational product or interfere with the
interpretation of data.

9. Are largely or wholly incapacitated permitting little or no self-care, such as being
bedridden or confined to a wheelchair.

10. Have an estimated glomerular filtration rate (eGFR) of <50 mL/min/1.73 m^².

11. Have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of
normal (ULN) or the most recent available total bilirubin =1.5 times ULN (if
available).

12. Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of
possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or
have active primary or recurrent malignant disease; or have been in remission from
clinically significant malignancy for < 5 years.

1. Subjects with uterine cervical carcinoma in situ that has been resected with no
evidence of recurrence or metastatic disease for at least 3 years may participate
in the study

2. Subjects with basal cell or squamous epithelial skin cancers which have been
completely resected with no evidence of recurrence for at least 3 years may
participate in the study.

13. Active infections, or history of recurrent infections or have required management of
acute or chronic infections as evidenced by any of the following:

1. Currently on any suppressive therapy for a chronic infection (such as
tuberculosis, cytomegalovirus, herpes simplex, herpes zoster, or atypical
mycobacteria).

2. History or suspicion of chronic infection (e.g. prosthetic joint infection)

3. Hospitalization for treatment of infection within 60 days of baseline visit

4. Use of parenteral (IV or IM) antimicrobials (antibacterial, antifungals,
antivirals, or antiparasitic agents) within 60 days of baseline or oral
antimicrobials within 30 days of baseline visit for treatment of an active
infection. This does not include the use of antibiotics for prophylaxis against
pneumocystis pneumonia since this is considered standard of care for patients on



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arteritis, Giant Cell

Intervention(s)

Drug: Baricitinib

Primary Outcome(s)

Adverse Events [Time Frame: 52 weeks]

Secondary Outcome(s)

C Reactive Protein (CRP) [Time Frame: week 0, week 24, week 52]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: week 0, week 24, week 52]

Giant Cell Arteritis (GCA) Relapse [Time Frame: 24 weeks, 52 weeks]

Secondary ID(s)

16-008993

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

Results

• Results available: Yes
• Date Posted: 08/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03026504