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The Standard care versus Celecoxib Outcome Trial
(SCOT trial)
A Large Streamlined Safety Study

The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to *usual-care* with their current non-…

Effects of Tocilizumab (RoACTEMRA) on biomarkers in synovial tissue of patients with rheumatoid arthritis

The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.The secondary objectives of this study are to:I. Assess clinical response at week 16;…

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

Part 1: To assess the safety and effectiveness of subcutaneous golimumab 50 mg (SC-GLM50), administered by autoinjection once monthly during 6 months, when combined with different DMARD regimens used in daily rheumatology. Part 2: In subjects who…

Long term prospective observational cohort study of the safety and efficacy of golimumab in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile

To determinate the efficacy and safety of golimumab in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.

Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

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 II study of ARA 290 as therapeutic strategy in rheumatoid arthritis

This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…

Long term prospective observational cohort study of the safety and efficacy of certolizumab pegol in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile

To determinate the efficacy and safety of certolizumab pegol in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with certolizumab pegol on the lipid profile will be monitored during…

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…

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

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

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…

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNF?? Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy

The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…

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…

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.

Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives.

1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?

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).…

Pilot Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-Inflammatory Pathway Using an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis

The primary efficacy objective is to determine the effect of NCAP on the clinical signs and symptoms of rheumatoid arthritis as assessed by the 28 Joint Disease Activity Score (DAS28).The secondary efficacy objectives are to determine the effect of…

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…