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Completed

NCT Number: NCT01609205

Doppler Evaluation in RA Patients After Adalimumab.

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Linköping University Hospital, Linköping, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Biological

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

Other names: Humira

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hamed Rezaei

Other

Collaborators

  • Abbott

Registry information

Official study 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

Acronym: Muscara

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 31, 2012
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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