Doppler Evaluation in RA Patients After Adalimumab. (Muscara)

Hamed Rezaei

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Biological: Adalimumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01609205

2012-002573-62 (EudraCT Number)

ClinTrid-US-1201

Details and patient eligibility

About

The purpose is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patient (> 18 years of age), male or female
Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
Moderate to high disease activity
Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
Signed Informed Consent *Signed Informed Consent must be obtained before any study specific procedures take place.

Exclusion criteria

Biologic treatment with Adalimumab before inclusion
Two or more ongoing biologic treatments before inclusion
Treatment with other biologic treatment than anti-TNF therapy before inclusion
Any contraindication for treatment with Adalimumab
Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
Positive for tuberculosis or hepatitis B.
Ongoing pregnancy or lactation