BIO BEHCET'S TRIA

Phase 1

Conditions: Behcets Disease
MedDRA version: 18.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-005390-36-GB

Lead Sponsor: The University of Liverpool

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

The inclusion criteria are adult individuals who are:
1. Diagnosed to have BD by International Study Group (ISG) criteria or International Criteria for BD (ICBD);
2. Have refractory disease as defined by the UK Centres of Excellence criteria (failure to respond to steroid and/or immunosuppressive therapy with significant or major organ-threatening disease) and therefore qualify for biologic therapy with either IFX or aIFN. A summary drugs pathway is attached as an appendix to the Protocol. Patients will have failed to respond to or have been intolerant of azathioprine at a dose of >2mg/kg (or comparable drug) and/or prednisolone at a dose of >40mg/day typically for more than three months, or with evidence of either organ threatening disease or unacceptable adverse events from immunosuppressive medication;
3. Able to give informed consent;
4. Have not previously received a biologic agent; and
5. Aged over 18 years.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The principal exclusion criteria are adult individuals who;
1. Have a contraindication to either IFX or aIFN (e.g., active infection, severe liver disease, neutropenia, previous malignancy);
2. Are not likely to comply e.g., cannot attend for assessments because of excessive travel requirements;
3. Express a strong preference for one of the two potential therapies.
4. Have heart disease or severe heart failure.
5. Have been diagnosed with Multiple Sclerosis.
6. Have evidence of infection with HIV.
or
7. . a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the study duration plus 6 months.
b) Women who are pregnant or breastfeeding.
c) Sexually active fertile men not using effective birth control if their partners are WOCBP.

Reproductive Status of Trial Participants
Definition of Women of Child-Bearing Potential (WOCBP)
WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below).
Post-menopause is defined as:
• Women who have had amenorrhea for ? 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL.
• Women who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.
• Women who are taking hormone replacement therapy (HRT).

The following women are WOCBP:
• Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
• Women who are practicing abstinence.
• Women who have a partner who is sterile (e.g. due to vasectomy).

WOCBP entering the trial must:
• Be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 6 months after the last dose of study drug in such a manner that the risk of pregnancy is minimised. The decision about the appropriate methods to be used to prevent pregnancy should be determined by discussions with the study subject.
• Have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
• Must not be breast-feeding.

Sexually active fertile men entering the trial must:
• Use effective birth control if their partners are WOCBP for the duration of the trial plus 6 months.