Trial record 5 of 34 for:    "Behcet Syndrome"

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00866359
First received: March 18, 2009
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.


Condition Intervention Phase
Behcet Syndrome
Drug: Apremilast (CC-10004)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • The change in the number of oral ulcers from Baseline to Day 85/Early Termination will be compared between the Apremilast and the placebo treatment groups. [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain of oral/genital ulcers [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]
  • # of ulcer free subjects & those with ≥ 50% reduction [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]
  • BD Current Activity Form score [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]
  • Safety (ECG, AE, Labs) [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: Yes ]
  • New BD manifestations [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]
  • PRO questionnaires [ Time Frame: Day 85 and Day 169 ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A. Apremilast Drug: Apremilast (CC-10004)

Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)

Placebo Comparator: B. Placebo Comparator Drug: Placebo

Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Behçet Disease. At the time of diagnosis, subjects must meet the international study group criteria for Behçet Disease
  • Females of childbearing potential (FCBP) must have negative pregnancy tests and agree to use two forms of contraception throughout the study.
  • Males must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP
  • Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL, platelet count ≥ 100,000 /microL,, serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L), total bilirubin ≤ 2.0 mg/dL, AST and ALT ≤ 1.5 X ULN
  • Two or more oral ulcers over the 28 day period before screening, with or without current treatment
  • Two or more oral ulcers at the time of randomization (Visit 2, Baseline)

Exclusion Criteria:

  • Pregnant or breast feeding
  • Any condition which places the subject at risk
  • Systemic fungal infection
  • History of TB infection within 3 years
  • History of recurrent bacterial infection
  • Mycobacterium TB as indicated by a positive PPD skin test
  • History of incompletely treated Mycobacterium tuberculosis
  • Clinically significant chest x-ray abnormality at screening.
  • Clinically significant ECG abnormality at screening
  • History of HIV infection
  • History of congenital or acquired immunodeficiency
  • Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
  • Antibodies to Hepatitis C at screening
  • History of malignancy (except for treated basal-cell skin carcinomas > 3 years prior to screening)
  • Any active major organ involvement of Behçet Disease
  • Use of concomitant immune modulating therapy or topical corticosteroids.
  • Use of ocular corticosteroids
  • Use of any investigational medication within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866359

Locations
United States, Florida
Mayo Clinic - Rheumatology and Internal Medicine
Jacksonville, Florida, United States, 32224
United States, Massachusetts
E5, Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Turkey
Eskişehir Osmangazi University
Eskişehir, Turkey, 26480
University of Istanbul
Istanbul, Turkey, 34098
Selçuk University
Konya, Turkey, 42080
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Yusuf Yazici, MD NYU Hospital for Joint Diseases
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00866359     History of Changes
Other Study ID Numbers: CC-10004-BCT-001, EudraCT#: 2008-002722-11
Study First Received: March 18, 2009
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Turkey: Ministry of Health

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014