TDM Guided Early Optimization of ADAL in Crohn's Disease

Sponsor
waqqas.afif
Study ID
NCT03261102
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

Key Dates

Start date
Jan 17, 2017
Status verified
May 2025
Primary completion
Jan 15, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard clinical care
    Adalimumab induction as per standard clinical care: * Week 0: 160 mg SC * Week 2: 80 mg SC * Followed by 40 mg SC every 2 weeks' maintenance therapy
  • Active Comparator: Active optimization
    Same as Standard clinical care Arm, except: * If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week * If ADAL trough \>15 μg/ml, no dose escalation and continued standard of care dosing

Primary Outcome Measure

Proportion of subjects who achieved remission [ Time Frame: Week 12 ]

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