Anakinra for Behcet s Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01441076
• Date of registration: 24/09/2011
• Prospective Registration: No
• Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Public title: Anakinra for Behcet s Disease
• Scientific title: A Pilot Study of Anakinra in Behcet's Disease (BD)
• Date of first enrolment: September 2011
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01441076
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Peter C Grayson, M.D.
• Affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Male or female subjects with BD associated inflammatory disease greater than or
equal 18 years of age

2. Participation in NIH study #03-AR-0173 ( Studies of the Natural History,
Pathogenesis, and Outcome of Autoinflammatory Diseases )

3. Diagnosis of Behcet s disease as determined by the International Study Group
Criteria [17] or by complete Japanese Criteria [18].

4. Active mucocutaneous disease as defined by at least one oral or genital ulcer
within the past month.

5. Stable dose of steroids, NSAIDs, DMARDs, or colchicine for four weeks prior to
enrollment visit.

6. For patients with ocular disease, no active intermediate or posterior disease at
enrolment but history of an ocular flare (greater than or equal to 3 in the last
6 months) in the presence of any systemic anti-inflammatory therapy such as
prednisone, azathioprine, Mycophenolate, methotrexate, cyclosporine, a tumor
necrosis factor (TNF) inhibitor, or a combination of these medications. Patients
must have developed active disease in the presence of at treatment with at least
one of the following medications for at least six months: azathioprine,
cyclosporine, or a TNF inhibitor.

7. Females of childbearing potential (young women who have had at least one
menstrual period regardless of age) must have a negative urine pregnancy test at
screening and a negative serum pregnancy test at baseline prior to performance of
any radiologic procedure or administration of study medication. Female patients
will be screened for pregnancy at all NIH visits.

8. Women of childbearing age and men able to father a child, who are sexually
active, who agree to use a form of effective birth control, including abstinence.

9. Either (1) a negative PPD test using 5 T.U. intradermal testing per Center for
Disease Control and Prevention guidelines and no evidence of active tuberculosis
(TB) on chest X-ray at the time of enrollment or (2) a positive PPD with no
evidence of active TB by history or on chest X-ray at the time of enrollment and
either past or present treatment with adequate therapy for at least one month
prior to first dose of study medication. Full prophylaxis regimens will be
completed. Subjects who have been Bacillus Calmette-Guerin (BCG)-vaccinated will
also be skin-tested.

10. Able to understand, and complete study-related questionnaires.

11. Able and willing to give informed consent and abide with the study procedures.

EXCLUSION CRITERIA:

1. Treatment with a live virus vaccine during 3 months prior to baseline visit. No live
vaccines will be allowed throughout the course of this study.

2. Patients with ocular disease who received local treatments other than eye drops (i.e.
periocular or intraocular steroids, implants or other anti-inflammatory agents within
4 weeks prior to enrolment)

3. Current treatment with TNF inhibitors or discontinuation of TNF inhibitors within 8
weeks.

4. Presence of active infections or a history of pulmonary TB infection. Patients with a
history of exposure to TB (positive PPD) who have not been treated with a TB
prophylaxis regimen for at least one month.

5. Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma
consistent with prior TB.

6. Positive test for or prior history of HIV, Hepatitis B or C.

7. History or concomitant diagnosis of congestive heart failure.

8. History of malignancy. Subjects deemed cured of superficial malignancies such as
cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be
enrolled.

9. Known hypersensitivity to Chinese Hamster Ovary (CHO) cell derived biologicals or any
components of anakinra.

10. Presence of any additional rheumatic disease or significant systemic disease. For
example, major chronic infectious/ inflammatory/ immunologic disease (such as
inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, systemic lupus
erythematosus in addition to autoinflammatory disease).

11. Presence of any of the following laboratory abnormalities at enrollment visit:
creatinine > 1.5 times the upper limit of normal , white blood cell < 3.6
times10(9)/mm(3); platelet count < 75,000 mm(3); alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) > 2.0 times the upper limit of normal

12. Lactating females or pregnant females.

13. Subjects with asthma not adequately controlled on current inhaled therapy for at least
four weeks.

14. Enrollment in any other investigational treatment study or use of an investigational
agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer,
since ending another investigational device or drug trial.

15. Subjects for whom there is concern about compliance with the protocol procedures.

16. Presence of other severe acute or chronic medical or psychiatric condition, or
significant laboratory abnormality requiring further investigation that may cause
undue risk for the subject s safety, inhibit protocol participation, or interfere with
interpretation of study results, and in the judgment of the investigator would make
the subject inappropriate for entry into this study.

17. Treatment within the past 12 months with canakinumab

18. Active neurologic disease which would require cyclophosphamide treatment. Active
neurologic disease is defined as either new evidence of parenchymal
(meningoencephalitis) or non-parenchymal (vascular complications including thrombosis)
disease.

19. Subjects who experience an end organ flare after discontinuation of a TNF inhibitor as
part of this study.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immune System Diseases

Autoimmune Connective Tissue Disorder

Intervention(s)

Drug: Anakinra

Primary Outcome(s)

Clinical Remission From Months 3-6 [Time Frame: Monthly study visits from months 3-6 during the trial]

Secondary Outcome(s)

Behcets Disease Current Activity Form (BDCAF) Score [Time Frame: Baseline]

Number of Genital Ulcers by Physician Evaluation [Time Frame: Baseline]

Number of Oral Ulcers by Physician Evaluation [Time Frame: Baseline]

Number of Oral Ulcers by Physician Evaluation [Time Frame: Month 6 study visit]

Behcet's Syndrome Activity Scale (BSAS) Score [Time Frame: Baseline]

Behcet's Syndrome Activity Scale (BSAS) Score [Time Frame: Month 6 study visit]

Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score [Time Frame: Baseline]

Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score [Time Frame: Month 6 study visit]

Behcets Disease Current Activity Form (BDCAF) Score [Time Frame: Month 6 study visit]

Number of Genital Ulcers by Physician Evaluation [Time Frame: Month 6 study visit]

Patient Global Score [Time Frame: Month 6 study visit]

Physician Global Score [Time Frame: Baseline]

Physician Global Score [Time Frame: Month 6 study visit]

Patient Global Score [Time Frame: Baseline]

Secondary ID(s)

11-AR-0241

110241

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01441076