Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario La Paz
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Patients > 18y

• Intensified adalimumab regime at least 4 weeks prior to enrollment.

• Immunosuppressants are allowed if a stable dose for > 12w is maintained.

• Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.

Exclusion Criteria:

• Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.

• Pregnant or lactating women.