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Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis

Information source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Takayasu's Arteritis; Giant Cell Arteritis

Intervention: Abatacept (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Official(s) and/or principal investigator(s):
Carol A. Langford, MD, MHS, Principal Investigator, Affiliation: The Cleveland Clinic

Overall contact:
Carol A. Langford, MD, MHS, Phone: 216-445-6056, Email: langfoc@ccf.org

Summary

Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.

Clinical Details

Official title: Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu's Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Remission duration

Secondary outcome: Drug toxicity

Detailed description: GCA and TAK both cause inflammation in the lining of the arteries, which can interfere with the body's ability to carry oxygen to areas that need it. Symptoms of GCA include headaches, jaw pain, and blurred or double vision. Serious symptoms that occur less commonly are blindness and stroke. TAK symptoms include fever, fatigue, weight loss, arthritis, and non-specific aches and pains. There may also be tenderness near affected arteries. Researchers believe that GCA and TAK are diseases that are controlled by the body's immune system. Activated T-cells, specifically, are critical to the origin and development of these diseases. Abatacept is a medication that modulates the signal required for T-cell activation. This study will evaluate the safety and effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.

Participation in this study may last up to 4 years. Participants will receive abatacept intravenously on specified days during Months 1, 2, and 3. They will also receive daily prednisone, which will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to either continue abatacept or be switched to placebo infusions. Both treatments will be given once a month at study visits. Blood samples will also be collected at the monthly study visits to conduct laboratory-based studies. Participants who remain in remission will continue to receive abatacept or placebo monthly until the common closing date, defined as 12 months after enrollment of the 33rd participant for each disease.

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of GCA or TAK (defined below)

- History of active GCA or TAK within the past 2 months

- Age of 15 years or older

- Willing to use an effective means of birth control throughout the study

Specific Inclusion Criteria for Participants with GCA:

- Participants must meet three of the following five criteria, including either

Criterion 4 or 5:

1. Age at disease onset was equal to or greater than 50 years

2. Disease onset was recent or experiencing a new type of localized pain in the head

3. Erythrocyte sedimentation rate greater than 40mm in the first hour, as determined using the Westergren method

4. Temporal artery abnormality (i. e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)

5. Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cell or characteristic changes of large vessel stenosis or aneurysm by arteriography

Specific Inclusion Criteria for Participants with TAK:

- Presence of abnormalities that are consistent with TAK identified using

arteriography, plus at least one of the following criteria:

1. Age at disease onset was less than 50 years

2. Pain in the legs or arms

3. Decreased brachial artery pulse (one or both arteries)

4. Difference of more than 10mm Hg in blood pressure between the arms

5. Bruit over subclavian arteries or aorta

Exclusion Criteria:

- Evidence of active infection (including chronic infection)

- Pregnant or breastfeeding

- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen

- Inability to comply with study guidelines

- Inability to provide informed consent

- Cytopenia, as defined by a platelet count of less than 80,000/mm3, an absolute

neutrophil count of less than 1,500/mm3, and hematocrit less than 20%

- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL

or creatinine clearance of 20 ml/min or less

- Other uncontrolled disease that could prevent safe study completion

- History of any malignant neoplasm except adequately treated basal or squamous cell

carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years

- Receipt of an investigational agent or device within 30 days prior to study entry

- A live vaccination within 4 weeks prior to study entry

- Presence of a positive tuberculin skin test with induration of at least 5mm

- Radiographic evidence suggestive of tuberculosis

- Poor tolerability of blood draws or lack of adequate access to veins for medication

administration and blood draws

- History of treatment with rituximab within 12 months prior to study entry or history

of treatment with rituximab more than 12 months prior to study entry, where the B lymphocyte count has not returned to normal

- History of treatment with infliximab within the past 49 days, adalimumab within the

past 28 days, or etanercept within the past 21 days.

- Presence of any of the following diseases or conditions:

1. Microscopic polyangiitis

2. Churg-Strauss syndrome

3. Polyarteritis nodosa

4. Cogan's syndrome

5. Behcet disease

6. Sarcoidosis

7. Kawasaki disease

8. Tuberculosis or atypical mycobacterial infection

9. Deep fungal infection

10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis

11. Cryoglobulinemic vasculitis

12. Systemic lupus erythematosus

13. Rheumatoid arthritis

14. Mixed connective tissue disease or any overlap autoimmune syndrome

Locations and Contacts

Carol A. Langford, MD, MHS, Phone: 216-445-6056, Email: langfoc@ccf.org

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Michael Weisman, MD, Phone: 310-360-9197
Michael Weisman, MD, Principal Investigator

Johns Hopkins Medical Center, Baltimore, Maryland 21224, United States; Recruiting
Philip Seo, MD, Phone: 410-550-6825
Philip Seo, MD, Principal Investigator

Boston University, Boston, Massachusetts 02118, United States; Recruiting
Paul Monach, MD, PhD, Phone: 617-414-2500
Paul Monach, MD, PhD, Principal Investigator

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Eric Matteson, MD, Phone: 507-284-8450
Steven Ytterberg, MD, Phone: 507-284-1625
Eric Matteson, MD, Principal Investigator

Hospital for Special Surgery, New York, New York 10021, United States; Recruiting
Robert Spiera, MD, Phone: 212-774-2123
Robert Spiera, MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Carol A. Langford, MD MHS, Phone: 216-445-6056
Carol A. Langford, MD MHS, Principal Investigator

St. Joseph's Hospital, Hamilton, Ontario L8P 3B3, Canada; Recruiting
Nader Khalidi, MD, Phone: 905-522-1155, Ext: 35873
Nader Khalidi, MD, Principal Investigator

Mt. Sinai Hospital Toronto, Toronto, Ontario M5T 3L9, Canada; Recruiting
Simon Carette, MD, Phone: 416-586-8616
Simon Carette, MD, Principal Investigator

University of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States; Recruiting
Kathleen Maksimowicz-McKinnon, DO, Phone: 412-648-4701
Kathleen Maksimowicz-McKinnon, DO, Principal Investigator

University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Curry Koening, MD, MS, Phone: 801-581-4993
Curry Koening, MD, MS, Principal Investigator

Additional Information

Click here for the Vasculitis Clinical Research Consortium Web site

Click here for the Cleveland Clinic Center for Vasculitis Care and Research Web site

Starting date: December 2008
Last updated: August 27, 2012

Page last updated: February 07, 2013

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