Does addition of subcutaneous interferon alpha 2b for 6 months only to the treatment of Behcet?s disease significantly reduce the number of patients requiring immunosuppressive agents to control their disease over the following 3 years?

Completed

• Conditions: Ophthalmology, rheumatology and immunology; Musculoskeletal Diseases; Other necrotizing vasculopathies

• Registration Number: ISRCTN36354474
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Added 03/06/2009:
1. Patient is male or female greater than 18 years of age
2. Patient has a diagnosis of Behcet's disease (as defined by the International Study Group criteria for Behcet's disease)
3. Patient requires systemic treatment, either:
3.1. With or without steroids, plus/or
3.2. A second-line agent for treatment of systemic or ocular disease, e.g., azathioprine, cyclosporine, methrotrexate, cyclophosphamide, cellcept, infliximab, tacrolimus
4. Patient is willing and able to have weekly subcutaneous injections of interferon alpha 2b for 26 weeks
5. Female patients of child-bearing potential agree to use an adequate form of contraception if randomised to receive interferon for 12 months
6. The patient has been on stable dose(s) of systemic medication for the past 4 weeks or patient will be able to maintain a stable dose of systemic medication 4 weeks before baseline visit in order to commence study
7. The patient anticipates being available for the duration of the study
8. The patient is prepared to be randomised to remain on their 'standard treatment' for the duration of the trial
9. Patients with ocular inflammation from Behcet's disease: it must possible to visualise the retina. The patient does not have major ocular media opacities such as large axial corneal scars, cataract and vitreous haemorrhage.
10. Patient is willing:
10.1. To attend for three monthly formal review for the first 6 months and then at 12, 18, 24 and 36 months for the clinical trial
10.2. More visits may be required for clinical needs
10.3. To the other aspects of follow-up, including access to their previous medical notes from the referring physician
11. Requiring systemic treatment with steroids and a second-line agent, or second-line agent(s) alone for either systemic or ocular disease
12. Able and willing to have weekly subcutaneous injections
13. Women may enrol only following counselling about the need for adequate contraception
14. Patients in whom the systemic medication has been changed within the last 4 weeks will be delayed entry to the trial until the drug dosages have been stable for 4 weeks or more

CMR study:
Patients with a contraindication to cardiovascular magnetic resonance will be suitable for enrolment in the trial but will not be invited for CMR scans. This includes patients with metallic implants and pacemakers, and patients with severe claustrophobia.

Exclusion Criteria

Added 03/06/2009:
1. Has the patient had any previous treatment with interferon?
2. Patient's weight is less than 50 kg
3. Patient has hypersensitivity to the active substance/any excipients/any interferon preparation
4. Patient has relevant drug allergy or contraindications to use of any of the medications
5. If female - is the patient pregnant, planning to become pregnant and/or breastfeeding
6. Does the patient have any of the following conditions:
6.1. Autoimmune hepatitis
6.2. History of a severe psychiatric disorder (including severe depression that required referral to a psychiatrist)
6.3. Severe renal dysfunction
6.4. Severe hepatic dysfunction
6.5. Epilepsy and/or compromised central nervous system dysfunction
6.6. Pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range by medication
7. Does the patient has any history of severe pre-existing cardiac disease including unstable or uncontrolled cardiac disease within the last 6 months
8. Is there any reason that the patient's participation in the clinical trial is inadvisable, according to best clinical judgement (e.g. significant medical history)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 03/06/2009:<br>1. The percentage of patients in each group who have quiescent disease enabling their steroid dose to be reduced to 10 mg or less and their second-line agent withdrawn during the follow-up period will be calculated<br>2. The number of ocular and systemic disease relapses over time will be compared between the two groups. These will be classified as mild, moderate or severe using pre-determined criteria. <br><br>CMR study:<br>1. Endothelial-dependent brachial artery flow-mediated dilatation<br>2. Total carotid artery wall volume (left and right)<br>3. Left and right ventricular end diastolic volume (LVEDV and RVEDV)<br>4. Left and right ventricular end systolic volume (LVESV and RVESV)<br>5. Left and right ventricular ejection fraction (LVEF and RVEF)<br>6. Left and right ventricular mass (LVM and RVM)

Secondary Outcome Measures

Name	Time	Method
Added 03/06/2009:<br>1. The number of new serious complications (vascular, neurological and ocular involvement) occurring over the follow-up period will be counted and compared to those in the group not given the IFN<br>2. The disease activity and chronic fatigue questionnaires will be scored and the scores added up and compared in the two groups as well as in each patient at the beginning and end of the study