Opal Study CNTO148UCO4001

• Research type

  Research Study

• Full title

  An Observational Prospective Long-term Exposure Registry of Adult Patients with Moderate-to-Severe Ulcerative Colitis.

• IRAS ID

  230370

• Contact name

  Bu Hussain Hayee

• Contact email

  b.hayee@nhs.net

• Sponsor organisation

  Janssen Biotech Inc

• Clinicaltrials.gov Identifier

  NCT02808780, Clinicaltrials.gov; EUPAS13986, EU PAS register

• Duration of Study in the UK

  14 years, 3 months, 1 days

• Research summary

  This is a voluntarily post-authorisation safety study of a previously approved drug called Simponi which is being tested in a real world environment.
  This study is taking place at a number of locations in approximately 25 countries around the world. In the UK it will be conducted in hospital clinics.
  It seeks to compare the incidence of lymphoma in adult patients (18 years or older) who have moderately to severely active Ulcerative Colitis (UC) for at least 3 months and who are being treated with either Simponi® or thiopurine based immunosuppressant drugs. In addition it is looking at the relative long term safety between the treatments based on recording the incidence of other malignancies (cancers) other than lymphoma, clinical status, quality of life of the patients, and use of health care facilities by the patients on both types of treatments.

  The study (registry) will review the long-term safety and effectiveness of Simponi® over a ten year period and will only monitor the safety and effectiveness of the drugs as they are standardly prescribed by medical staff. There will be no change to any patient treatment as a result of the study except patients health will be assessed by the patients completing 5 minute quality of life questionnaire's at hospital visits and later over the phone when they are no longer attending hospital.

  Another sponsor is performing a similar UC study where it is anticipated that 2750 enrolled patients will be treated with thiopurines. The patients on this study will be offered inclusion in the Opal study and after consenting their data will be shared and analysed with the data from the Opal study. This will in effect reduce the number of patients enrolled on the thiopurine arm of this study.
  The protocol for this PASS study has been approved by the FDA.

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0285

• Date of REC Opinion

  14 Aug 2017

• REC opinion

  Favourable Opinion