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MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS

To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…

Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

To determine the proportion of patients with RA, AS or PsA maintaining minimal disease activity (MDA) after dose interval prolongation of etanercept. Secondary objectives: To study the cost-effectiveness of tapering down etanercept treatment, to…

Phase IIa, 2:2:1 randomised, double-blind, placebocontrolled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

The primary objective of the study is:Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.The Secondary objective is:Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg…

Efficacy analysis of several drugs in a humanized mouse model of psoriasis

In this study, the efficacy of different type drugs, on the development of the psoriatic process in the humanized mouse model for psoriasis, will be evaluated. These different, registered drugs intervene at different levels of the psoriatic process…

Efficacy of a novel compound in a humanized mouse model of psoriasis

ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated.

A Single-Center, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects

The purpose of this research is to investigate the safety and tolerability of MSB0010841. This study will also investigate how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics…

Phase IIB, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active
Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous
Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid
Arthritis with Inadequate Response to Methotrexate.

Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…

Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab

Until recently there were only few therapeutic options to treat AS. Efficacy is proven for several tumor necrosis factor (TNF)-blocking agents, including golimumab. 2-8 However, up to now, the efficacy of golimumab treatment on EAMs, like anterior…

An open label, single dose study to assess the pharmacokinetics of a microdose of recombinant human placental alkaline phosphatase (hRESCAP, part 1) followed by a randomized, double-blind, placebo-controlled, parallel, single ascending dose, first-in-human study to assess safety and tolerability of hRESCAP (part 2) in healthy male volunteers

Part 1:- To assess the PK of a single iv microdose (<=30 nmol) of recombinant human placental alkaline phosphatase (hRESCAP);- To assess if microdosing is a suitable technique to predict the PK of recombinant proteins using hRESCAP as model…

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…

Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of abatacept in patients with active rheumatoid arthritis.The secondary objectives of this study are to (I) assess clinical…

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

The primary objective of the study is to evaluate the long term safety of SAR153191 in patients with RA on top of DMARDs. The secondary objective of the study is finding the percentages of patients who reach ACR20, DAS28 and EULAR response overtime.

A partly blinded single center trial studying the effect of daily oral treatment with 30 mg prednisolone during two weeks on metabolic and disease activity parameters in patients with severe chronic atopic dermatitis and in healthy volunteers

Primary objectives:• To explore whether daily oral treatment with 30 mg prednisolone modulates biomarkers for adverse metabolic effects in a similar manner in patients with chronic atopic dermatitis as compared to healthy volunteers.• To determine…

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

Validation of dried blood spot sampling in therapeutic drug monitoring of cyclosporin

Validation of the DBS sampling method of cyclosporin in TDM practice

Study On The Effectiveness Of Oral Administration Of Prolyl Endoprotease For Gluten Detoxification As A Means To Treat Coeliac Disease

To determine if AN-PEP is capable of detoxifying gluten in vivo in patients diagnosed with coeliac disease

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy

Primary Objective* To assess the safety, tolerability, and efficacy (in terms of change in DAS28 [using C-ReactiveProtein (CRP)] from baseline) of JNJ-38518168 at a dose of 100 mg/day for up to 12 weekscompared to placebo in subjects with active…

A Phase I, Single-Centre, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CH-4051 in healthy male subjects

To evaluate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of CH-4051.