Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).

Phase 1

• Conditions: This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.; MedDRA version: 14.1 Level: PT Classification code 10058948 Term: Nephritis autoimmune System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.1 Level: PT Classification code 10049046 Term: Autoimmune thyroiditis System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1 Level: PT Classification code 10061664 Term: Autoimmune disorder System Organ Class: 10021428 - Immune system disorders; MedDRA version: 14.1 Level: LLT Classification code 10068004 Term: Autoimmune hyperthyroidism System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1 Level: PT Classification code 10050245 Term: Autoimmune thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005606-30-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Study Completion: 2017-08-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

To be included in the trial the patient must have/be: • Male or non-pregnant, non-lactating female patients • Aged between 18 and 50 years inclusive • Diagnosis of MS using McDonald’s criteria, including diagnostic MRI • Onset of first MS symptoms within 10 years • EDSS score 0.0 to 5.0 (inclusive) at screening • At least 2 clinical episodes of MS in the 2 years prior to study entry, with at least 1 attack within 12 months, which may have occurred whilst on disease-modifying therapy, such as beta interferon therapy or glatiramer acetate. • Serum IL-21 =230pg/mL. Apart from the IL-21 inclusion criterion, the details of patient selection are identical to those adopted in the phase 3 trials of alemtuzumab (CARE MS1 and MS2). This ensures that the results of this trial can be generalised to these patient groups.
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 86
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The presence of any of the following will preclude patient inclusion: •Any progressive form of multiple sclerosis •Previous thymectomy •Previous treatment with alemtuzumab, mitoxantrone, cyclophosphomide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) •History of malignancy •Personal history of clinically significant autoimmune disease, other than multiple sclerosis (including but not limited to: thyroid disease, immune cytopenias, inflammatory bowel disease, diabetes, lupus, severe asthma) •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis •Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results. •Seropositivity for human immunodeficiency virus (HIV) •Past or present hepatitis B infection (positive hepatitis B serology) •Pregnant women or male and female patients who do not agree to use effective contraception during the study. Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal based contraception, surgical sterilisation, abstinence, or double barrier contraception i.e. condom and occlusive cap (diaphragm or cervical cap with spermicide). • Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified