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Doppler Evaluation in RA Patients After Adalimumab. (Muscara)

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ClinicalTrials.gov Identifier: NCT01609205
Recruitment Status : Recruiting
First Posted : May 31, 2012
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Adalimumab Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Biological: Adalimumab
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
Other Name: Humira

Outcome Measures

Primary Outcome Measures :
  1. The proportion of different clinical (EULAR) response [ Time Frame: 6 months from BL ]
    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.

Secondary Outcome Measures :
  1. The proportion of patients with good response to add-on therapy [ Time Frame: 6 and 12 months from BL ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609205

Contact: Hamed Rezaei, MD +46 8 517 704 89 hamed.rezaei@sll.se

Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Michael Ziegelasch, MD    +46 (0)10 103 21 86    michael.ziegelasch@lio.se   
Principal Investigator: Michael Ziegelasch, MD         
The karolinska Institute Recruiting
Stockholm, Sweden, 171 76
Contact: Hamed Rezaei, MD    +46 (0)8 517 704 89    hamed.rezaei@sll.se   
Principal Investigator: Hamed Rezaei, MD         
Sponsors and Collaborators
Hamed Rezaei
Study Chair: Monica Rydén Aulin, Phd Karolinska Institutet
More Information

Responsible Party: Hamed Rezaei, Chief Arthritis, Inflammation department, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01609205     History of Changes
Other Study ID Numbers: ClinTrid-US-1201
2012-002573-62 ( EudraCT Number )
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents