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CompletedNCT00696059HURRAHUpdated Jun 12, 2008

Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

A Phase 4 interventional study of Adalimumab (Humira) in Rheumatoid Arthritis, Arthritis and Joint Diseases, sponsored by Hvidovre University Hospital. Completed at 5 sites in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-06-12.

Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Arthritis
  • Joint Diseases

Keywords

  • Rheumatoid arthritis
  • Computed tomography
  • Magnetic resonance imaging
  • Radiography
  • Tumor necrosis factor alpha antagonists
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 52 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Other
    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)

Interventions

  • DrugAdalimumab (Humira)

    Adalimumab (Humira) 40 mg subcutaneously every other week

    Also known as: Humira

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

5 sites
  • Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet
    Copenhagen, DK-2100, Denmark
  • Department of Rheumatology, Bispebjerg University Hospital
    Copenhagen, DK-2400, Denmark
  • Department of Rheumatology, Gentofte University Hospital
    Hellerup, DK-2900, Denmark
  • Department of Rheumatology, Herlev University Hospital
    Herlev, DK-2630, Denmark
  • Department of Rheumatology, Hvidovre University Hospital
    Hvidovre, DK-2650, Denmark
08

References and documents

Publications

  • Krabbe S, Bolce R, Brahe CH, Dohn UM, Ejbjerg BJ, Hetland ML, Sasso EH, Chernoff D, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller J, Ostergaard M. Investigation of a multi-biomarker disease activity score in rheumatoid arthritis by comparison with magnetic resonance imaging, computed tomography, ultrasonography, and radiography parameters of inflammation and damage. Scand J Rheumatol. 2017 Sep;46(5):353-358. doi: 10.1080/03009742.2016.1211315. Epub 2016 Sep 28. PubMed 27682742 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00696059
Lead sponsor
Hvidovre University Hospital
Collaborators
Abbott
First posted
Jun 12, 2008
Start date
Aug 2004
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jun 12, 2008

Study contacts

Mikkel Østergaard, Professor
principal investigator · Department of Rheumatology, Hvidovre University Hospital
Uffe Møller Døhn, M.D
study chair · Department of Rheumatology, Hvidovre University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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