BIOmarker-driven DEcision Study with Adalimumab (BIODESA)
| ISRCTN | ISRCTN61158084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61158084 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/07/2008
- Registration date
- 30/09/2008
- Last edited
- 30/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rainer H Straub
Scientific
Scientific
Franz-Josef-Strauss-Allee 11
D-93053
Regensburg
93042
Germany
| rainer.straub@klinik.uni-regensburg.de |
Study information
| Study design | Phase III, non-randomised, double-blind (participants and physicians), two-arm, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Individualised therapy of rheumatoid arthritis with anti-tumour necrosis factor (TNF) antibodies (adalimuab) based on neuroendocrine biomarkers, a prospective clinical study |
| Study acronym | BIODESA |
| Study objectives | Patients with a biomarker value (cortisol/adrenocorticotropic hormone [ACTH]) below 196,000 are responders to adalimumab treatment as demonstrated by a significantly better outcome (Disease Activity Score using 28 joints [DAS28]). The ratio of serum cortisol/serum ACTH can be used as a biomarker. |
| Ethics approval(s) | Application was submitted to the Ethics Committee of the University of Regensburg on 20/07/2008. Approval expected to be granted in October 2008. |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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 (s.c.) every other week for 24 weeks. The patients and the treating physicians do not know the group allocation. We expect that patients with a cortisol/ACTH ratio above 196,000 do not profit much from the anti-TNF therapy, whereas those patients with a ratio below 196,000 will profit from adalimumab therapy. According to good clinical care guidelines, we will have a rescue line at week 12. Those patients that do not profit from the therapy are switched to standard DMARD therapy with methotreaxte and prednisolone. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Adalimuab |
| Primary outcome measure | DAS28 at 12 weeks. |
| Secondary outcome measures | 1. Response to hormonal challenge test (corticotropin releasing hormone [CRH], growth hormone releasing hormone [GHRH], thyrotropin releasing hormone [TRH], and luteinizing hormone releasing hormone [LHRH] 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-betahydroxysteroid-dehydrogenase type 2 as investigated in miniarthroscopically removed synovial tissue (before and after anti-TNF therapy) |
| Overall study start date | 01/01/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 comorbidities (e.g. infectious, metabolic, hepatic, cardiac, malignant, psychiatric comorbidities) 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Franz-Josef-Strauss-Allee 11
Regensburg
93042
Germany
93042
Germany
Sponsor information
University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Internal Medicine
Franz-Josef-Strauss-Allee 11
93053
Regensburg
93042
Germany
| rainer.straub@klinik.uni-regensburg.de | |
| Website | http://www.uniklinikum-regensburg.de |
"ROR" |
https://ror.org/01226dv09 |
Funders
Funder type
Hospital/treatment centre
University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
No information available
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) - Decision pending
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
