Condition category
Musculoskeletal Diseases
Date applied
29/07/2008
Date assigned
30/09/2008
Last edited
30/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 [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)

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 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

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

http://www.uniklinikum-regensburg.de

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

Publication citations

Additional files

Editorial Notes