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Pain Modulation in Rheumatoid Arthritis (RA) - Influence of Adalimumab (PARADE)

This study is currently recruiting participants.
Verified August 2011 by Karolinska Institutet
Sponsor:
Collaborators:
Abbott
Swedish Foundation for Strategic Research
The Swedish Research Council
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01197144
First received: September 3, 2010
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to obtain increased knowledge concerning central pain and fatigue processing in rheumatoid arthritis, and how these conditions are influenced by treatment with Tumor Necrosis Factor (TNF) blockade with adalimumab.


Condition Intervention
Arthritis, Rheumatoid
Pain
Fatigue
 Drug: adalimumab
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Pain Modulation in RA - Influence of Adalimumab. A Randomized, Placebo-controlled Study Using Functional Magnetic Resonance Imaging (PARADE)

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:
  • Pain processing as measured by Blood Oxygen Level Dependent (BOLD) patterns in functional Magnetic Resonance Imaging (fMRI) of the brain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The main purpose of the study is to investigate effects of treatment/placebo on central nervous pain processing, measured with fMRI.


Secondary Outcome Measures:
  • Fatigue Visual Analogue Scale (VAS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The treatment effects on Fatigue VAS will be measured and related to fMRI data.


Estimated Enrollment: 90
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab
Treatment with adalimumab 40 mg sc eow for 4 weeks
 Drug: adalimumab
Subcutaneous, 40 mg every other week for 4 weeks
Other Names:
  • ATC code L04AB04
  • CAS 331731-18-1
Placebo Comparator: Placebo
Treatment with placebo s c eow for 4 weeks
 Drug: Placebo
Subcutaneous, every other week for 4 weeks
Other Name: Placebo, no other name
No Intervention: Healthy Controls

Healthy volunteers, age ≥18. Will perform all the same pain assessments, blood sampling and baseline fMRI as RA patients

Exclusion criteria:

For fMRI - left handedness and all forms of metallic implants.

  • Fulfilling ACR criteria for fibromyalgia.
  • Severe ischemic heart disease.
  • Concurrent treatment for depression/anxiety with antidepressant drugs.
  • Concurrent neurological disease.
  • Other reason as evaluated by the P.I.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18
  • Fulfilling American College of Rheumatology (ACR) criteria for RA.
  • Disease duration ≤ 5 years.
  • Either under treatment with methotrexate (in a maximum tolerable up to 20 mg/week orally or subcutaneously), or previous treatment with methotrexate withdrawn due to documented side effects.
  • Patients should be bio-naïve.
  • Disease activity: Disease Activity Score (DAS28)>3.2 and Swollen joint count (SJC)>1 and Tender Joint Count (TJC)>1.

Exclusion Criteria:

For fMRI - left handedness and all forms of metallic implants.

  • Fulfilling ACR criteria for fibromyalgia.
  • Severe ischemic heart disease.
  • Concurrent treatment for depression/anxiety with antidepressant drugs.
  • Contraindication to adalimumab.
  • Active or latent tuberculosis.
  • Chronic infections including hepatitis B or C.
  • Malignancy, multiple sclerosis, Systemic lupus erythematosus.
  • Other reason as evaluated by the PI.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197144

Contacts
Contact: Jon Lampa, MD, PhD +46 8 51770000 jon.lampa@karolinska.se
Contact: Gunnel Bemerfeldt, Coordinator +46 8 5177 30 20 gunnel.bemerfeldt@ki.se

Locations
Sweden
MR Centre, Dep of Clinical Neuroscience Recruiting
Stockholm, Sweden, SE-171 76
Contact: Eva Kosek, Assoc Prof     +46 8 524 800 00     eva.kosek@ki.se    
Sub-Investigator: Eva Kosek, Assoc Prof            
Dep of Rheumatology Recruiting
Stockholm, Sweden, SE-171 76
Contact: Jon Lampa, MD, PhD     +46 8 51770000     jon.lampa@karolinska.se    
Principal Investigator: Jon Lampa, MD, PhD            
Sponsors and Collaborators
Karolinska Institutet
Abbott
Swedish Foundation for Strategic Research
The Swedish Research Council
Investigators
Study Chair: Lars Klareskog, Professor Karolinska Institutet
Principal Investigator: Jon Lampa, MD, PhD Karolinska Institutet
  More Information

Publications:

Responsible Party: Jon Lampa, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01197144     History of Changes
Other Study ID Numbers: MR20100114, 2009-017163-42
Study First Received: September 3, 2010
Last Updated: August 16, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
TNF
functional Magnetic Resonance Imaging
Autonomic
Vagus
adalimumab

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

ClinicalTrials.gov processed this record on May 21, 2013