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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

This study is not yet open for participant recruitment.
Verified June 2012 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: June 1, 2012
Last verified: June 2012
History of Changes
  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:

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

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 2015
Estimated Primary Completion Date: September 2015 (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
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
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 Not yet 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 Not yet 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
  More Information

No publications provided

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: June 1, 2012
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013