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Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers.

Primary:- assess safety and tolerability and determine the maximum tolerated dose (MTD) of repeated doses or a single dose of AZ01 given as a subcutaneous (SC) or intravenous (IV) dose in healthy subjects. Dosing will not exceed the maximum feasible…

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis.

Primary objective:To determine the safety and tolerability of multiple doses of MOR103 in patients with active rheumatoid arthritis, at ascending dose levels.Secondary objectives:- to evaluate signs of efficacy of MOR103 in patients with active…

A PHASE I/II, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY, WITH A SINGLE ASCENDING DOSE PART FOLLOWED BY A MULTIPLE ASCENDING DOSE PART, EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF INTRAVENOUS ALX-0061 IN PATIENTS WITH RHEUMATOID ARTHRITIS

Primary:to investigate the safety and tolerability of single and multiple doses of the study drug given by intravenous injection/infusion to patients with RAto determine the maximum tolerated dose and/or biologically effective dose of the study…

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.

To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…

The Patient based Disease Activity Score (PDASII) validation study

The aim of this study is to assess the effect of training on the measurement properties of a recently developed disease activity score based on patient reported outcomes and to investigate if such a measure could be implemented in current clinical…

A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy

Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…

Effect of mindfulness on patients with rheumatoid arthritis:
a controlled effect study

The present study will test the effect of MBSR on RA in comparison to cognitive behavioral therapy (CBT) and a no-treatment control group. It is hypothesized that Mindfulness will be at least as effective in changing quality of life, psychological…

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

The aim of the study is to evaluate the efficacy and safety of three IV treatment regimens of sifalimumab in adult subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE (Standard Of Care treatment for SLE).…

A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2)

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and…

A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…

A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…

Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis

The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…

Randomized double blind placebo controlled PK/PD study on the effects of a single intravenous dose of NOX-H94 on serum iron during experimental human endotoxemia

Primary Objective•To assess the pharmacodynamic response after single dose administration of NOX H94 in healthy subjects during experimental endotoxemia.Secondary Objective• To determine the pharmacodynamic effects of NOX H94 after single dose…

Effectiveness of the online self management training ReumaUitgedaagd! for young adults with Juvenile Idiopathic Arthritis (JIA)

The objective of this research is to study the effectiveness of the online zelfmanagementtraining ReumaUitgedaagd! by young adults with Juvenile Idiopathic Arthritis (JIA) who are treated on the transition outpatient clinic of the departments…

Double dose treatment: Corticosteroid injection therapy in arthritis

To determine whether doubling the dose of corticosteroid injections in the treatment of arthritis in knee joints is more effective in the relief of symptoms as measured by change in the assessment of arthritis burden by the patient on a Likert 5-…

Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis

Primary objective:- To determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by OCT. Secondary objectives: - To investigate whether the occurrence of a second attack (defining clinically definite MS) is…

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled 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 efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…

Potential optimalisation of (Expediency) and Effectiveness of TNF-blockers

The primary goal of this study is to determine whether it is possible to discontinue treatment with TNF blocking therapy in patients suffering from RA when the patient has had stable low disease activity, without the occurence of an exacerbation.

A randomised, double-blind, placebo-controlled,
multicentre prospective dose-finding Phase II/III study
with atacicept given subcutaneously to subjects having
recently experienced a flare of systemic lupus
erythematosus (SLE)

PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

To compare the impact of adding sitagliptin to usual care vs. usual care without sitagliptin with regard to the risk of developing cardiovascular events.