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Search / Trial NCT01197144

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

Launched by KAROLINSKA INSTITUTET · Sep 8, 2010

Trial Information

Current as of June 20, 2025

Completed

Keywords

Tnf Functional Magnetic Resonance Imaging Autonomic Vagus Adalimumab

ClinConnect Summary

Background

Rheumatoid arthritis (RA) RA is characterized by joint inflammation causing peripheral pain, however the relation between peripheral pathology and pain intensity is weak. There is substantial evidence that also pain modulation mechanisms are dysregulated in RA. For example, generalized pain frequency is higher in RA than in normal population, about 15% compared to 3%. Earlier data from our group show a changed pattern of pain-modulation in established RA compared to early RA and controls (Keystone 2004).

There are several treatments in RA directed at relieving symptoms (NSAIDs)...

Gender

ALL

Eligibility 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(in a maximum tolerable up to 20 mg/week orally or subcutaneously), or previous treatment with methotrexate withdrawn due to documented side effects.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.

About Karolinska Institutet

Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.

Locations

Stockholm, , Sweden

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Lars Klareskog, Professor

Study Chair

Karolinska Institutet

Jon Lampa, MD, PhD

Principal Investigator

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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