Behcets Disease MedDRA version: 18.1 Level: LLT Classification code 10004212 Term: Behcet's disease System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Product Code: 3400935113276
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: infliximab
CAS Number: 170277-31-3
Current Sponsor code: PF-064381
Sponsors
The University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to underpin clinically effective prescribing of the biologic drugs infliximab (IFX) and alpha interferon (aIFN) for Behçet’s Disease (BD). The primary objective of the study is to undertake a randomised controlled trial to compare IFX versus aIFN in patients with BD who are unresponsive to standard oral therapy. ;Secondary Objective: The secondary objectives of the study are to; (1) examine whether IFNL3 and IFNL4 SNPs can predict response to aIFN and/or IFX in BD, and (2) examine the potential for urine metabolomics to act as a biomarker for drug response to IFX and/or aIFN in BD.;Primary end point(s): The primary outcome will be a modified version of the Behçet’s Disease Activity Index (BDAI) after three months of therapy, which will range from 0 to 30 for a patient.;Timepoint(s) of evaluation of this end point: After three months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Modified BDAI after six months of treatment • Significant improvement in organ involvement within (a) the primary organ system that resulted in the decision to start a biologic agent and (b) other organ systems assessed by: (I)Ocular: reduction in vitreous haze using the SUN consensus group grading scale and visual acuity change from baseline. A reduction of 2 or more is considered to be clinically significant. (II) Oral ulcer activity: change in ulcer severity score (USS). An improvement of 20% is considered to be clinically meaningful. (III) Change in number of genital ulcers: a reduction of 50% is considered to be clinical significant. (IV) Musculoskeletal: Likert pain score (an improvement of 20% is considered to be clinically meaningful) • Adverse events in each group • Reduction in dose of prednisolone (or equivalent glucocorticoid) at three months: a clinically meaningful reduction is considered to be 50% of baseline or dose of <15mg/day prednisolone • Reduction in dose of prednisolone (or equivalent glucocorticoid) at six months: a clinically meaningful reduction is considered to be 50% of baseline or dose of <7.5mg/day prednisolone. • Quality of life scores at three months and six months compared to baseline. The QoL instruments used will be EQ-5D and BD-QoL: a reduction of 20% would be of clinical importance • Physician’s Global Assessment of disease activity (a 7 point Likert Scale completed as part of (but assessed independently of) the BDAI) i) at 3 months and ii) at 6 months. ;Timepoint(s) of evaluation of this end point: After three and six months of treatment. | — |
Countries
United Kingdom
Contacts
Public ContactMiss Charlotte Rawcliffe
Liverpool Clinical Trials Unit
Outcome results
None listed