GO OBSERVE: A European observational study in adults with moderate to severe ulcerative colitis in which the patient reports his or her response to SIMPONI at home through a website.
- Conditions
- C, ulcerative colitis, IBD, golimumab, SIMPONI
- Registration Number
- NL-OMON22604
- Lead Sponsor
- MSD B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
Adult age
- Established diagnosis of UC since at least 3 months
Exclusion Criteria
- Child or adolescent age.
- Contraindication to anti-TNF therapy according to drug labelling: active infection, non-treated latent tuberculosis, congestive heart failure (NYHA: Grade III and IV), malignancy during the previous 5 years (except non-melanoma skin cancer), demyelinating neurological disease.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of UC patients with patient-reported Continuous Clinical Response (pCCR) to golimumab (SIMPONI) after induction (at week 6, 10 or14) through week 54 based on stool frequency and rectal bleeding score (PRO2)
- Secondary Outcome Measures
Name Time Method