search
Back to results

Doppler Evaluation in RA Patients After Adalimumab. (Muscara)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Hamed Rezaei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköping University Hospital
  • The karolinska Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Adalimumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 29, 2012
Last Updated
April 24, 2018
Sponsor
Hamed Rezaei
Collaborators
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT01609205
Brief Title
Doppler Evaluation in RA Patients After Adalimumab.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hamed Rezaei
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Adalimumab
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
Primary Outcome Measure Information:
Title
The proportion of different clinical (EULAR) response
Description
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.
Time Frame
6 months from BL
Secondary Outcome Measure Information:
Title
The proportion of patients with good response to add-on therapy
Description
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.
Time Frame
6 and 12 months from BL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Rydén Aulin, Phd
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
The karolinska Institute
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Doppler Evaluation in RA Patients After Adalimumab.

We'll reach out to this number within 24 hrs