GP2017 and Humira in moderate to severe active rheumatoid arthritis

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel-group, multicentre study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis

• IRAS ID

  200919

• Contact name

  Julia Jauch

• Contact email

  julia.jauch@sandoz.com

• Sponsor organisation

  Hexal, AG

• Eudract number

  2015-003433-10

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This study is planned to randomise approximately 308 male and female patients with moderate to severe active rheumatoid arthritis (RA) at approximately 115 study sites worldwide.

  A screening period of up to 4 weeks will be used to assess patient´s eligibility. All patients must be on stable dose of methotrexate (MTX) at least 4 weeks prior to randomisation and continue throughout the study on this dose.

  In Study Period 1, eligible patients will be randomised using a 1:1 ratio to one of the two treatment arms: GP2017 (study drug) or Humira® (adalimumab)by sub-cutaneous injection for a 24 week period. Study drug administration will be performed by site staff. At Week 24 all patients will be evaluated for their response. Patients who did not show at least a moderate response will have their final assessment at Week 24 and will not continue in the study.

  In Study Period 2, irrespective of their treatment during Study Period 1, all patients with at least a moderate response at Week 24, will be switched to or continue with subcutaneous injection of GP2017 from Week 24 up to Week 46. All patients will self-administer GP2017 injections.
  
  End of Study Visit will be performed at Week 48.

  Total maximum duration of the study for a patient is approximately 53 weeks.

  A chest X-Ray (CXR) may be performed prior to screen visit or at baseline visit, if imaging (computed Tomography (CT scan)or Magnetic Resonance Imaging (MRI scan) or chest x-ray) not available within 3 months of randomisation.
  During study treatment the following will be performed: physical examination; Vital signs including weight, heart rate and blood pressure; Blood tests and urine sample;
  Electrocardiogram (ECG), Patient Questionnaires and Study treatment administration.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  16/LO/0702

• Date of REC Opinion

  5 Jul 2016

• REC opinion

  Further Information Favourable Opinion