Baricitinib in Relapsing Giant Cell Arteritis

NCT03026504 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 16-008993
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteritis, Giant Cell

Outcome Measures

Primary Outcomes (1)

• Adverse Events

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

  52 weeks

Secondary Outcomes (3)

• Giant Cell Arteritis (GCA) Relapse

  24 weeks, 52 weeks

• Erythrocyte Sedimentation Rate (ESR)

  week 0, week 24, week 52

• C Reactive Protein (CRP)

  week 0, week 24, week 52

Study Arms (1)

Baricitinib Therapy

EXPERIMENTAL

4 milligrams oral Baricitinib daily for 52 weeks

Drug: Baricitinib

Interventions

Baricitinib DRUG

4 milligrams oral Baricitinib daily for 52 weeks

Also known as: JAK2 Inhibitor

Baricitinib Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.)
• 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.

You may not qualify if:

• 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).
• Subjects demonstrating symptoms of visual loss (transient or permanent blindness) or diplopia attributable to GCA.
• Subjects with history of aortic dissection, myocardial infarction, or cerebrovascular attack attributable to GCA.
• 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.
• Organ transplant recipients.
• 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.
• 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
• 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.
• Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to a wheelchair.
• Have an estimated glomerular filtration rate (eGFR) of \<50 mL/min/1.73 m\^².
• 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).
• 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.
• 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
• 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.
• Active infections, or history of recurrent infections or have required management of acute or chronic infections as evidenced by any of the following:

Sponsors & Collaborators

• Matthew J Koster: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Koster MJ, Crowson CS, Giblon RE, Jaquith JM, Duarte-Garcia A, Matteson EL, Weyand CM, Warrington KJ. Baricitinib for relapsing giant cell arteritis: a prospective open-label 52-week pilot study. Ann Rheum Dis. 2022 Jun;81(6):861-867. doi: 10.1136/annrheumdis-2021-221961. Epub 2022 Feb 21.

  PMID: 35190385 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Matthew Koster, M.D.
• Organization: Mayo Clinic

koster.matthew@mayo.edu

507-284-5800

Study Officials

• Kenneth Warrington, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: March 9, 2017
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)