Study to Assess the Safety & Tolerability of MED15117 in RA Patients.

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MED15117 (anti-IL-6).

• IRAS ID

  102829

• Contact name

  David J A Bell

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-005402-29

• Research summary

  This is a first time in man study of MEDI5117, a monoclonal antibody. It is a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose study. The safety, tolerability, pharmacokinetic & pharmacodynamic and immunogenicity (ability of a particular substance to provoke an immune response in the body) of single intravenous doses of MEDI5117 in male and female patients with rheumatoid arthritis aged 20 to 75 years will be evaluated. It is a Multicentre study planning to recruit 32 patients in total, with 4 dose cohorts receiving different doses of study drug or placebo. A safety review committee (SRC) will determine if a 5th cohort is needed and will determine the dose. A further 8 patients will participate in the 5th cohort, making the maximun mumber of particpants 40. The starting dose will be 30mg and provisional doses will be 100, 300, and 600mg. A safety review committee will determine the exact dose of MEDI5117 to be given to patients in each dose level and they will determine if a 5th cohort is needed and what the dose will be. Each cohort will be randomized as follows: 6 patients on MEDI5117 and 2 placebo. First cohort will receive 30mg MEDI5117 or placebo. The actual dose for subsequent cohorts will be determined after review of data from the previous cohort. The study drug or placebo will be administered via IV infusion over approx 60 mins using an infusion pump. After first dose patients will be discharged from the clinic on Day 2. Patients who receive the study drug will return for a total of 22 follow-up visits. Those on placebo will complete at week 12. Duration for each patient dosed with the study drug is approx 68 weeks (including 30 day screening period, 2 days in the clinic and 450 days follow-up).

• REC name

  HSC REC B

• REC reference

  12/NI/0038

• Date of REC Opinion

  30 Mar 2012

• REC opinion

  Further Information Favourable Opinion