Clinical Trials

The range of services for joint research projects and contract research within the division of Clinical Research at Fraunhofer TMP includes all the necessary infrastructure requirements and expertise to conduct clinical trials, in accordance with all national and international regulations, including studies according to AMG and MPG. Clinical indication-specific technical expertise is assured for all immune-mediated and inflammatory diseases on the basis of the close connection and cooperation with clinical centers at the Goethe University Hospital. Our emphasis is on the detection of appropriate target populations, choosing the best possible endpoints and the use of innovative bio-statistical evaluation methods.

Within this business unit, the following studies are carried out:

  • Proof-of-Concept (POC) studies
  • Early drug development up to Phase II b
  • Clinical studies on the pathophysiology, genetics, imaging and pharmacodynamics of selected diseases

Selected Publications

Behrens F, Tak PP, Østergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial. Ann Rheum Dis. 2015 Jun;74(6):1058-64. doi: 10.1136/annrheumdis-2013-204816. Epub 2014 Feb 17.

Kaltwasser JP, Nash P, Gladman D, Rosen CF, Behrens F, Jones P, Wollenhaupt J, Falk FG, Mease P; Treatment of Psoriatic Arthritis Study Group. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: a multinational, double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum. 2004 Jun;50(6):1939-50.

Behrens F, Koehm M, Arndt U, Wittig BM, Greger G, Thaçi D, Scharbatke E, Tony HP, Burkhardt H. Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational Study. J Rheumatol. 2016 Mar;43(3):632-9. Doi 10.3899/jrheum.141596. Epub 2015 Dec 15.