Doppler Evaluation in RA Patients After Adalimumab.

Rheumatoid Arthritis Clinical Trial

— Muscara  

Official title:

Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609205
• Other study ID #: ClinTrid-US-1201
• Secondary ID: 2012-002573-62
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2012
• Last updated: April 24, 2018
• Start date: October 2012
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Adalimumab
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	The karolinska Institute	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Hamed Rezaei	Abbott

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of different clinical (EULAR) response	The primary endpoint will be the proportion of different clinical (EULAR) response (good, moderate, no response)* to add-on therapy with anti-TNF treatment at 6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.	6 months from BL
Secondary	The proportion of patients with good response to add-on therapy	The proportion of patients with good response to add-on therapy (measured by both Doppler and clinical assessment) at 6 and 12 months follow-up visits in two groups of patients, those who achieve low disease activity according to Doppler assessment at 3 months visit versus those who did not.	6 and 12 months from BL