Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of Crohn’s Disease for at least 6 weeks, with active inflammation confirmed by endoscopy.

Eligibility criteria also require a Crohn’s Disease Activity Index (CDAI) score greater than 150 and a history of non-response or intolerance to conventional therapies.

Participants are randomly assigned to receive either azathioprine or methotrexate in combination with adalimumab.

Azathioprine is administered orally in the form of a film-coated tablet, while methotrexate is given as a subcutaneous injection.

Adalimumab is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol and adjusted as necessary during follow-up visits.

Participants continue their assigned treatment regimen throughout the study duration, with regular monitoring and adjustments as needed.

Regular follow-up visits are scheduled to monitor clinical response and remission. These visits occur at specified intervals, including weeks 12, 26, 52, 78, and 104.

During these visits, assessments include clinical evaluations, blood tests for C-reactive protein (CRP) and calprotectin levels, and endoscopic examinations.

An endoscopic evaluation is conducted at week 26 to assess the primary endpoint, which is a decrease of at least 50% in the Simple Endoscopic Score for Crohn’s Disease (SES-CD) compared to baseline.

Secondary endpoints include endoscopic remission and ulcer-free endoscopy.

Throughout the study, the necessity for adalimumab optimization is evaluated, and adjustments are made as required.

Participants are monitored for any adverse events, and medication withdrawal is considered if necessary.

The study is estimated to conclude by September 2027, with final assessments conducted to evaluate long-term outcomes and any necessary follow-up care.