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

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ClinicalTrials.gov Identifier: NCT01197144
Recruitment Status : Unknown
Verified February 2016 by Jon Lampa, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : September 9, 2010
Last Update Posted : February 5, 2016
Sponsor:
Collaborators:
Abbott
Swedish Foundation for Strategic Research
The Swedish Research Council
Information provided by (Responsible Party):
Jon Lampa, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Pain Fatigue Drug: adalimumab Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : October 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pain processing as measured by Blood Oxygen Level Dependent (BOLD) patterns in functional Magnetic Resonance Imaging (fMRI) of the brain [ Time Frame: 4 weeks ]
    The main purpose of the study is to investigate effects of treatment/placebo on central nervous pain processing, measured with fMRI.


Secondary Outcome Measures :
  1. Fatigue Visual Analogue Scale (VAS) [ Time Frame: 4 weeks ]
    The treatment effects on Fatigue VAS will be measured and related to fMRI data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197144


Contacts
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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
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Sweden
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         
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         
Sponsors and Collaborators
Karolinska Institutet
Abbott
Swedish Foundation for Strategic Research
The Swedish Research Council
Investigators
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Study Chair: Lars Klareskog, Professor Karolinska Institutet
Principal Investigator: Jon Lampa, MD, PhD Karolinska Institutet

Publications:

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Responsible Party: Jon Lampa, MD, PhD, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01197144     History of Changes
Other Study ID Numbers: MR20100114
2009-017163-42 ( EudraCT Number )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Keywords provided by Jon Lampa, Karolinska Institutet:
TNF
functional Magnetic Resonance Imaging
Autonomic
Vagus
adalimumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Fatigue
Joint Diseases
Musculoskeletal Diseases
Signs and Symptoms
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents