GUSELKUMAB, GOLIMUMAB for Crohn's disease (moderately to severely active)

Inclusion criteria

• {"criterion_text":"- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline\n- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)\n- Demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effect\n- If female and of childbearing potential, must meet the contraception and reproduction requirements"}

Exclusion criteria

• {"criterion_text":"- Complications of CD that may be anticipated to require surgery\n- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery\n- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks\n- Has a draining (example, functioning) stoma or ostomy\n- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for greater than or equal to (>=)12 months before the first dose of study intervention\n- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer\n- Presence on screening ileocolonoscopy of adenomatous colonic polyps, if not removed before study entry, or history of adenomatous colonic polyps that were not removed.\n- Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 16 weeks before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Treatment and repeat testing can occur in the current screening period."}

Primary endpoints

• {"endpoint_text":"- Clinical remission and endoscopic response at Week 48 compared with each monotherapy","definition_or_measurement_approach":"As stated in the record: Clinical remission and endoscopic response at Week 48 compared with each monotherapy. No further endpoint definition provided in the record; disease activity assessments referenced elsewhere in the application include CDAI, stool frequency, abdominal pain score and SES-CD."}

Primary sponsor

Full Name

Janssen - Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Multiple sponsor/CRO responsibilities (trial management, data management and other duties listed in sponsorDuties)

Name

Excelya Greece CRO Single Member S.A.

Responsibilities

Support in submission

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties listed (codes); contact info: info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCoA; other sponsor duties (code listed)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Multiple sponsor duties (codes listed); contact: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging services; other sponsor duties (code listed)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Support in submission; other sponsor duties","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Histopatholoogy image review","organisation_type":"Pharmaceutical company"}