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A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Primary Objective is to evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents.The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

The primary objective of the study is to determine whether baricitinib 4 mg QD is superior toplacebo in the treatment of patients with moderately to severely active RA who have had an inadequate response to a TNF inhibitor, despite ongoing treatment…

A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy.

The primary objective of the study is to determine whether baricitinib is superior to placebo in the treatment of patients with moderately to severely active rheumatoid arthritis (RA) despite methotrexate treatment (ie, inadequate response to…

A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA).

Primary ObjectiveThe primary objective of this study is to compare prospectively in patients treated with TCZ or etanercept (ETA), the time to first occurrence of any component of a composite of major adverse cardiovascular events (MACE) consisting…

A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…

Endoscopic treatment of salivary glands affected by Sjögren Syndrome; A pilot study

The focus of this pilot study is to investigate the results of a sialendoscopy (with or without rinsing with hydrocortisone 100mg) on the unstimulated whole mouth (UWS) and stimulated parotid (SP) (ml/min) flow of saliva, oral dryness, reported…

A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.

The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…

A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis

The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) SC in maintaining remission in subjects with nr-axSpA.

Cognitive-behavioral therapy and exercise training to treat fatigue in Sjögren*s syndrome, non-Sjögren*s sicca syndrome, rheumatoid arthritis and systemic lupus erythematosus, a randomized controlled trial

The aim of the study is to examine in 144 patients with primary Sjögren*s syndrome, non-Sjögren sicca syndrome, rheumatoid arthritis and systemic lupus erythematosus, whether a intervention consisting of cognitive-behavioural therapy combined with…

Dose-to-target of etanercept treatment:
a dose-tapering randomized controlled trial in patients with juvenile idiopathic arthritis in patients age 12 years and older.

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects with Rheumatoid Arthritis

The purpose of the study is to investigate to what extent FPA008 is safe and tolerated, specifically what side effects the drug (FPA008) may have at different dose levels, when given intravenously over approximately 30 minutes. The study will also…

A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy

This study has two parts. The main purpose of Part 2 of this study is to see how safe and effective different doses of BI 655064 are as well as to look at the pharmacokinetics (the amount of medication in your blood) and the pharmacodynamics (the…

A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (Abbvie) in Healthy Adult Subjects

Primary ObjectiveTo demonstrate pharmacokinetic comparability of ONS-3010 (Oncobiologics), US-licensed Humira®, and EU-licensed Humira® following a single 40-mg subcutaneous (SC) dose in healthy adult subjects.Secondary ObjectiveTo evaluate the…

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…

A randomized, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks (q3W) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (TED)

The primary objective is to investigate the efficacy, safety and tolerability of RV 001 (a fully human anti-IGF-1R antibody) administered q3W for 6 months, in comparison to placebo, in the treatment of patients suffering from active TED.Secondary…

A study to assess the safety, tolerability and pharmacokinetic properties of CEP-37248, a drug for the treatment of autoimmune inflammatory diseases, in healthy men.

The purpose of the study is to investigate to what extent CEP-37248 is tolerated. Also investigated is how quickly and to what extent CEP-37248 is processed by the body (PK). In addition, the effect of the compound on how much IL-12 and IL-23 is in…

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-…

Rheumates@work: an interactive internet program to promote physical activity in children with juvenile idiopathic arthritis

To improve physical activity levels and physical activity patterns in children with JIA by means of cognitive behavioural training based on the social cognitive theory and the health promotion model, delivered by internet and supported by group…

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…

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

To evaluate the efficacy and safety of nilotinib in spondyloarthritis