Adalimumab dose optimization in rheumatoid arthritis using drugconcentration in blood (ADDORA): multi-center open label randomizedcontrolled trail

Phase 1

• Conditions: Rheumatoid arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001554-25-NL
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

-rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria
- adalimumab < 16 weeks at registered dose of 40mg every other week
-who has agreed to participate (written informed consent);
-age 16 years or older.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 167
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Life expectancy shorter than follow-up period of the study;
-Other disease that might flare if adalimumab is tapered like psoriasis,
inflammatory bowel disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified