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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…

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…

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.

IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease;A randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent.

The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…

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…

A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone

The purpose of this 5-year trial is to determine if the surgical procedure, extended transsternal thymectomy (ETTX), combined with prednisone therapy is more beneficial in treating individuals with non-thymomatous MG than prednisone therapy alone.

Twin SUBLIVAC® Grasses Clinical Efficay Study

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.

A randomized, double-blinded, placebo-controlled, single centre, phase I study of the safety of escalating single intravenous doses of NI-0801 in healthy volunteers.

To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.

When and in whom to stop etanercept after successful treatment of Juvenile Idiopathic Arthritis

Hypothesis:A substantial proportion of the JIA patients in remission (according to the Wallace criteria) will be able to discontinue etanercept successfully.Goals:To investigate in a randomized controlled trial:- which proportion of JIA patients in…

Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes.

Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…

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…

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Primary Objective: The primary objective of the study is to assess long-term safety of AMG 108 (125 mg, 250 mg) SC in subjects with RA previously enrolled in study 20050168.Secondary Objective(s): The secondary objectives of the study are:* To…

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFα Chimeric Monoclonal Antibody (infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis (DINORA Study)

The primary objective of the study is to demonstrate that patients with very early arthritis have a higher probability of achieving a state of clinical remission at end of infliximab therapy if treated with infliximab plus MTX when compared to MTX…

A Randomized Controlled Trial into the effect of a fall prevention program tailored for patients with Rheumatoid Arthritis

The objective of the study is to evaluate a fall prevention program for persons with RA. The primary parameter is to reduce fall incidence in the participants of the fall prevention program.

A Phase IIIB multicentre, randomized, double*blind, double dummy study to compare the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate.

The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .