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Abatacept treatment in patients with primary Sjögren*s syndrome: an open label study

Evaluation of efficacy (as assessed by the stimulated whole saliva flow rate at 24 weeks) and safety of abatacept treatment in 15 patients with pSS.

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).…

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…

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…

An open label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with psoriatic arthritis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease

The primary objective of the study is to assess the safety and immunogenicity of V212 in a population of adults with autoimmune disease.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate Efficacy and Safety of Treatment with CNTO 136 Administered Intravenously in Subjects with Active Lupus Nephritis

Primary Objective(s)The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously in subjects with active, ISN/RPS Class III and IV LN.Secondary ObjectivesThe secondary objectives are:Evaluate the…

ANTI-IGE THERAPY (OMALIZUMAB)
IN IGE-ACPA POSITIVE RHEUMATOID ARTHRITIS
Addendum: An open label extension study to provide continuation of anti-IgE therapy to Rheumatoid Arthritis patients who participated in the TIGER study P10.161

- To evaluate the safety and efficacy of anti-IgE therapy with respect to:Clinical disease activity (DAS44), laboratory parameters and adverse events. - To evaluate whether disease activity correlates with immunological parameters, including…

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…

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…

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…

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…

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 26-week, phase II, multicenter, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients.

To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…

Probiotics in atherosclerosis: a pilot study

The objective of the study is to see whether oral administration of probiotics can modulate certain immunological markers which are associated with accelarated atherosclerosis in patients with ANCA associated vasculitis.

Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study

The primary objective of this study will be overall response to treatment with Estetrol in patients with primary Sjogren*s syndrome.

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Primary Objective:To preliminarily evaluate the efficacy of GLPG0259 compared with placebo in terms of the proportion of subjects achieving ACR20 at Week 12 (Visit [V]7).Secondary Objectives:•To evaluate the efficacy of GLPG0259 compared with…

Efficacy and safety of adalimumab in patients with peripheral spondyloarthritis without ankylosing spondylitis or psoriatic arthritis.

The aim of the study is to assess the efficacy and safety of treatment with adalimumab in patients with peripheral spondyloarthritis (without AS of PsA). Furthermore, the effect of adalimumab will be investigated on systemic and local disease…

A randomized, double-blind, placebo-controlled, phase 2a study of the efficacy, safety, and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.

This is the first study of MLN3897 in any disease population. It seeks to establish:1) The ability of MLN3897 to modify the signs and symptoms of RA.2)The safety and tolerability of MLN3897 in combination with MTX.3)The PK/PD profile of MLN3897 in…