Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-021146-22-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-25
• Study Completion: 2014-11-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

All study participants must be able and willing to provide informed consent prior to any study-specific procedures, including immunisation. NOTE: Alemtuzumab recipients who do not wish to take part in the study (i.e. attend Addenbrooke’s for study procedures as outlined in Protocol Section 13.1, including blood samples with/without vaccination), but who are happy for morbidity information only to be collected via a phone call or via GP records on one occasion only (as per screening/baseline visit) will indicate their intention in writing on the study Expression of Interest” form. Alemtuzumab recipients (cases) • Received alemtuzumab in original Cambridge studies (1991-94) Matched controls • Rheumatoid arthritis according to 1987 ACR criteria • Disease duration within 5 years of matched case • Age within 10 years of matched case • Gender profile to match alemtuzumab recipients
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Both groups • Contra-indications to vaccination (as per SmPCs – see protocol Appendices B-D) • Recent vaccination with study strain of flu vaccine • Vaccination with tetanus, diphtheria, polio or pneumococcus within past 5 years (contra-indication to the specific vaccine only) Controls only • Received rituximab within past 3 months • Treatment with any investigational agent within 12 weeks or 5 half-lives of the investigational drug NOTE: Eligible patients (control or alemtuzumab cohort) who have received vaccination with pneumococcus, tetanus, diphtheria, or polio within the past 5 years will not be excluded from the study, but will NOT be revaccinated with the specific vaccine as relevant, i.e. Revaxis and/or Pneumovax II. NOTE: Eligible patients (control or alemtuzumab cohort) who are also women of child-bearing potential will have pregnancy status checked by a serum pregnancy test at the screening visit. Women who are subsequently confirmed as pregnant or who are breast feeding will NOT be excluded from the study but will NOT receive any of the three vaccines at the screening/baseline visit. Results from the serum pregnancy test (where relevant) must be obtained prior to vaccination. For relevant female patients whose pregnancy test is negative, a separate baseline visit is needed for vaccination only (once pregnancy results are known). The separate baseline visit must be within 7 days of the screening visit; the date of vaccination (baseline) would then be Day 0.

Study & Design

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