Doppler Evaluation in RA Patients After Adalimumab. (Muscara)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Karolinska Institutet
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ronald van Vollenhoven, prof., Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01609205
First received: May 29, 2012
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Rheumatoid Arthritis
Biological: Adalimumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • The proportion of different clinical (EULAR) response [ Time Frame: 6 months from BL ] [ Designated as safety issue: No ]
    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:
  • The proportion of patients with good response to add-on therapy [ Time Frame: 6 and 12 months from BL ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Adalimumab
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609205

Contacts
Contact: Ronald van Vollenhoven, MD, Prof. +46 8 517 76077 ronald.van.vollenhoven@ki.se

Locations
Sweden
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 70489    hamed.rezaei@karolinska.se   
Principal Investigator: Ronald van Vollenhoven, MD, Prof.         
Sub-Investigator: Hamed Rezaei, MD         
Sponsors and Collaborators
Ronald van Vollenhoven, prof.
Abbott
Investigators
Study Chair: Peter Westerling, phd Karolinska Institutet
  More Information

Responsible Party: Ronald van Vollenhoven, prof., Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01609205     History of Changes
Other Study ID Numbers: ClinTrid-US-1201  2012-002573-62 
Study First Received: May 29, 2012
Last Updated: February 23, 2016
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 21, 2016