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Humira in Rheumatoid Arthritis - Do Bone Erosions Heal? (HURRAH)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00696059
First received: June 9, 2008
Last updated: June 11, 2008
Last verified: June 2008
History of Changes
  Purpose

Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira) therapy.


Condition Intervention Phase
Rheumatoid Arthritis
Arthritis
Joint Diseases
 Drug: Adalimumab (Humira)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • By means of computed tomography and magnetic resonance imaging to investigate if repair of bone erosion occurs in rheumatoid arthritis joints during adalimumab (Humira) therapy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: August 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Open-label, one arm only. All patients receiving active drug according to recommendations (adalimumab (Humira) 40 mg subcutaneously every other week).
 Drug: Adalimumab (Humira)
Adalimumab (Humira) 40 mg subcutaneously every other week
Other Name: Humira

Detailed Description:

Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that radiographic erosions scores decreased in some patients. This suggests that erosive damage may "heal" in some RA patients treated with anti-TNF. However, it is not clarified whether the reduced scores are caused by technical issues as observer variation and image acquisition differences. Furthermore, radiography of erosions is a 2D representation of a 3D pathology and therefore not ideal for visualizing healing, if present. Verification of erosion healing under anti-TNF therapy with adalimumab (Humira) by optimal imaging methods, would markedly influence our perception of the effect and potential of adalimumab (Humira) for modifying structural joint damage in RA. Magnetic Resonance Imaging (MRI), allowing high-resolution 3D visualization of bone damage as well as the inflammatory activity in the bone (bone marrow edema/osteitis), is more sensitive for visualization of bone erosions than radiography. Computed Tomography (CT) is a 3D radiographic imaging technique, which is not suited for assessment of inflammation, but can be considered a reference method for assessment of bone damage, due to its direct 3D visualization of calcified tissue. Internationally recommended MRI scoring systems as well as methods for estimation of erosion volumes have been developed, with participation by our research group. Ultrasonography (US), even though less validated, is more sensitive than radiography and comparable to MRI in detecting bone erosions in RA joints. Additionally, US provides visualisation of soft tissue changes and synovitis, using gray-scale and Doppler US.

Repeated MRI, CT, US and radiographic examinations of RA joints with mild to moderate radiographic damage under adalimumab (Humira) therapy will allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira) therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 criteria
  • Moderate or severely active RA, defined as a DAS28(CRP)> 3.2
  • Moderate radiographic structural joint damage, defined as Larsen grade 2-3, in ≥ 2 wrist and/or MCP joints
  • No previous biological therapy
  • Clinical indication for biological therapy, according to the treating physician
  • Treatment with methotrexate and folic acid for at least 4 weeks prior to inclusion
  • No history of tuberculosis, and no signs of tuberculosis at chest radiograph or Mantoux test.
  • No contra-indications for TNF-alpha antagonist treatment
  • Co-operability of the patient, including that the patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations
  • Oral and signed informed consent by the patient

Exclusion Criteria:

  • Acute infection, and known chronic viral infection such as HIV or hepatitis B and C
  • Other DMARDs than methotrexate within last 4 weeks before inclusion
  • Intramuscular or intraarticular glucocorticoids within last 4 weeks before inclusion
  • Oral treatment with prednisolone >10 mg per day
  • Malignant lymphoma and other malignant disease
  • Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease (including demyelinating disease))
  • Pregnancy and lactation. Patients must use safe anti-conception during the treatment.
  • Development of SLE-like disease. Occurrence of positive ANA and/or anti-DNA antibodies without clinical symptoms is not considered a contra-indication.
  • Contra-indications for MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696059

Locations
Denmark
Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100
Department of Rheumatology, Bispebjerg University Hospital
Copenhagen, Denmark, DK-2400
Department of Rheumatology, Gentofte University Hospital
Hellerup, Denmark, DK-2900
Department of Rheumatology, Herlev University Hospital
Herlev, Denmark, DK-2630
Department of Rheumatology, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Abbott
Investigators
Principal Investigator: Mikkel Østergaard, Professor Department of Rheumatology, Hvidovre University Hospital
Study Chair: Uffe Møller Døhn, M.D Department of Rheumatology, Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Mikkel Østergaard, Department of Rheumatology, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00696059     History of Changes
Other Study ID Numbers: HUM 04-20
Study First Received: June 9, 2008
Last Updated: June 11, 2008
Health Authority: Denmark: Ethics Committee
Denmark: National Board of Health
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Rheumatoid arthritis
Computed tomography
Magnetic resonance imaging
Radiography
Tumor necrosis factor alpha antagonists

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

ClinicalTrials.gov processed this record on May 23, 2013