Doppler Evaluation in RA Patients After Adalimumab.

NCT01609205 | Completed Phase 4 DMC

• 2 other identifiers: ClinTrid-US-12012012-002573-62
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months from BL

Secondary Outcomes (1)

• The proportion of patients with good response to add-on therapy

  6 and 12 months from BL

Study Arms (1)

Arm 1

EXPERIMENTAL

Adalimumab

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

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

Also known as: Humira

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamed Rezaei: lead
• Abbott: collaborator

Study Sites (2)

Linköping University Hospital

Linköping, Sweden

Location

The karolinska Institute

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Monica Rydén Aulin, Phd

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Arthritis, Inflammation department

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)