Clinical trial · Interventional
Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?
Can Bone Erosions Heal in Adalimumab (Humira) Treated Rheumatoid Arthritis Patients. An Imaging Study Using Computed Tomography and Magnetic Resonance Imaging.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis | — | UNRESOLVED | — |
| Joint Diseases | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adalimumab (Humira) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- Open-label, one arm only. All patients receiving active drug according to recommendations (adalimumab (Humira) 40 mg subcutaneously every other week).
- interventionNames
- Drug: Adalimumab (Humira)
Primary outcomes (1)
- 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
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKrabbe 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. PMID 27682742