AzTrials
AzTrials

Rheumatoid ArthritisPhase 4HURRAHNCT00696059

Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

A Phase 4 study testing Adalimumab (Humira) in people with Rheumatoid Arthritis and Arthritis, run by Hvidovre University Hospital at 5 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rheumatoid Arthritis, Arthritis, Joint Diseases
What is being tested?
Adalimumab (Humira)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
5 sitesDenmark
Study dates
Aug 2004to Jul 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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))
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Department of Rheumatology, Copenhagen University Hospital, Rigshospitalet

    Copenhagen, DK-2100

  • Department of Rheumatology, Bispebjerg University Hospital

    Copenhagen, DK-2400

  • Department of Rheumatology, Gentofte University Hospital

    Hellerup, DK-2900

  • Department of Rheumatology, Herlev University Hospital

    Herlev, DK-2630

  • Department of Rheumatology, Hvidovre University Hospital

    Hvidovre, DK-2650

Other trials in Denmark

About this study

Official title: Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.

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.

Being tested
Adalimumab (Humira)
Keywords
Rheumatoid arthritis, Computed tomography, Magnetic resonance imaging, Radiography, Tumor necrosis factor alpha antagonists
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab (Humira)Drug

    Also called Humira

    Adalimumab (Humira) 40 mg subcutaneously every other week

Study groups in NCT00696059
Study groupRoleWhat they receive
1OtherOpen-label, one arm only. All patients receiving active drug according to recommendations (adalimumab (Humira) 40 mg subcutaneously every other week).
Receives: Drug: Adalimumab (Humira)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2008 (estimated)
  2. Study startAug 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00696059
Sponsor's protocol ID
HUM 04-20
Acronym
HURRAH
Status last verified
Jun 2008
First submitted
9 Jun 2008
Last updated
12 Jun 2008
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab (Humira) in people with Rheumatoid Arthritis and Arthritis, run by Hvidovre University Hospital at 5 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00696059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in