Search for a trial

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE FOR INDUCING AND SUSTAINING CLINICAL RESPONSE IN THE TREATMENT OF DMARD-NAÏVE ADULTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…

A phase III, multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety of Tocilizumab in subjects with giant cell arteritis.

Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…

Cytokine inhibition in Chronic Fatigue Syndrome patients - a pilot study

To investigate the effect on symptomatology of interference with IL-1 in CFS patients.

Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune response during experimental human endotoxemia

Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE).

Primary Objective - To determine if afamelanotide can reduce the severity of PLE related pruritis.Secondary Objectives- To determine if afamelanotide can reduce the frequency of PLE episodes;- To determine if afamelanotide can reduce the duration of…

The effects of immunostimulation with GM-CSF or IFN-γ on immunoparalysis following
human endotoxemia.
A parallel randomised double-blind placebo-controlled study

Primary objective: The primary objective of the study is to determine the effects of GM-CSF/IFN-γ on the in vivo immunoparalysis induced by human endotoxemia. This will be determined by measuring plasma levels of various pro and anti-inflammatory…

A PHASE I, RANDOMIZED, DOUBLE BLIND PLACEBO * CONTROLLED, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OCID 2987 IN HEALTHY MALE SUBJECTS

Primary:-To determine the safety and tolerability of ascending single and multiple oral doses of OCID 2987 in healthy male subjects.Secondary:-To determine the pharmacokinetics (PK) of single and multiple oral dose OCID 2987 in healthy male subjects…

Single-center, double-blind, randomized, placebo-controlled, single-ascending dose
and food interaction study to investigate the tolerability, safety, pharmacokinetics,
and pharmacodynamics of ACT-389949 in healthy male subjects

• to evaluate the safety and tolerability of ascending single oral doses of the test compound ACT-389949 (test medication) in healthy male subjects• to study how the test compound ACT-389949 is absorbed, broken-down and excreted by the body and how…

In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human - VECTOR II study

- Primary objective: The effect of C1-INH prior to induction of a systemic inflammation by endotoxin (E. coli lipopolysaccharide), on the leukocyte phenotype, activation and mobilization. - Secondary objectives: - Determine the effect of C1-…

A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis

ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…

A multicenter, double-blind, randomized, active controlled, parallel-group study
to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions
compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis
treated with methotrexate (MTX)

Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…

A study proposal to investigate the sequels of mucosal inflammation caused by ETEC infection- the effects of probiotics

The main objective of this study is to investigate the effect of probiotics on the sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as total faecal output, relative faecal dry weight and mucin excretion in…

Bosentan (Tracleer®) in patients with Behçet*s disease: a Pilot Study.

· To determine therapeutic efficacy of Tracleer in patients with active Behcet disease. Furthermore:· To study cytokine and immunological patterns and ET-1levels in those patients.

A PROSPECTIVE RANDOMIZED STUDY ON THE EFFICACY AND SAFETY OF THE PROPHYLACTIC USE OF RITUXIMAB, ADDED TO STANDARD IMMUNOSUPPRESSIVE TREATMENT IN COMPARISON WITH STANDARD IMMUNOSUPPRESSIVE TREATMENT ALONE IN RENAL TRANSPLANTATION

To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.To assess the anti-inflammatory effects of EA-230 in patients with systemic inflammation following cardiac surgery. To assess the effects…