Contact information
Type
Scientific
Primary contact
Prof Rainer H Straub
ORCID ID
Contact details
Franz-Josef-Strauss-Allee 11
D-93053
Regensburg
93042
Germany
rainer.straub@klinik.uni-regensburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Individualised therapy of rheumatoid arthritis with anti-tumour necrosis factor (TNF) antibodies (adalimuab) based on neuroendocrine biomarkers, a prospective clinical study
Acronym
BIODESA
Study hypothesis
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
Application was submitted to the Ethics Committee of the University of Regensburg on 20/07/2008. Approval expected to be granted in October 2008.
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
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Adalimuab
Primary outcome measures
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 trial start date
01/01/2009
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Franz-Josef-Strauss-Allee 11
Regensburg
93042
Germany
Sponsor information
Organisation
University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Sponsor details
Department of Internal Medicine
Franz-Josef-Strauss-Allee 11
93053
Regensburg
93042
Germany
rainer.straub@klinik.uni-regensburg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) - Decision pending
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary