BIOmarker-driven DEcision Study with Adalimumab (BIODESA)

ISRCTN	ISRCTN61158084
DOI	https://doi.org/10.1186/ISRCTN61158084
Protocol serial number	N/A
Sponsor	University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Funders	University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany), German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) - Decision pending

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

Franz-Josef-Strauss-Allee 11
D-93053
Regensburg
93042
Germany

Email	rainer.straub@klinik.uni-regensburg.de

Study information

Primary study design	Interventional
Study design	Phase III, non-randomised, double-blind (participants and physicians), two-arm, controlled trial
Secondary study design	Non randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Adalimuab
Primary outcome measure(s)	DAS28 at 12 weeks.
Key secondary outcome measure(s)	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)
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes