Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
The participants will be allocated to two groups according to a biomarker
the biomarker is the ratio of serum levels (in mol/l) of cortisol divided by ACTH (cortisol/ACTH). Both groups are treated with the already approved anti-TNF antibody adalimumab 40 mg subcutaneously (
Sponsors
University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Rheumatoid arthritis (RA) is diagnosed according to the American College of Rheumatology criteria 2. Both males and females, age must be 18 years or older 3. Patients must have given written informed consent 4. The disease duration should be less than 24 months 5. The DAS28 score must be above 5.0 6. The number of swollen joints must be >=8 7. The number of tender joints must be >=10 8. The erythrocyte sedimentation rate must be >=28 mm/hour
Exclusion criteria
Exclusion criteria: 1. Other inflammatory arthropathies such as psoriasis arthritis and similar conditions 2. Treatment with disease modifying anti-rheumatic drugs (DMARDs), glucocorticoids, or biologics 3. Severe or uncontrolled co?morbidities (e.g. infectious, metabolic, hepatic, cardiac, malignant, psychiatric co?morbidities) 4. A positive screening test result for tuberculosis (purified protein of tuberculin 5 [PPD5] test, chest radiography). Patients at high risk for tuberculosis are excluded or are treated with isoniazid up to 300 mg/day concomitantly. 5. Patients of child-bearing potential without adequate contraceptive protection 6. Patients with contraindications for trial drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response to hormonal challenge test (corticotropin releasing hormone [CRH], growth hormone releasing hormone [GHRH], thyrotropin releasing hormone [TRH], and luteinizing hormone releasing hormone [LH?RH] before and after anti-TNF therapy) 2. Behaviour of circadian rhythm curves of cortisol, testosterone, and DHEA (before and after anti-TNF therapy) 3. Volume and morphology of the adrenal glands (magnetic resonance imaging [MRI] before and after anti-TNF therapy) 4. Volume of the anterior cingulate cortex (MRI before and after anti-TNF therapy) 5. Expression of 11-beta?hydroxysteroid-dehydrogenase type 2 as investigated in miniarthroscopically removed synovial tissue (before and after anti-TNF therapy) | — |
Countries
Germany
Outcome results
None listed