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A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

Objectives: • To provide continuing treatment to subjects with SLE who complete HGS1006-C1056 or HGS1006-C1057.• To evaluate the long-term safety and tolerability of belimumab in subjects with SLE.

Development of Tools (and prediction rules) to time and select therapy in treatment of pre-clinical, early and established Rheumatoid Arthritis: Creating Enhanced Remedy (TRACER): early rheumatoid arthritis

to combine and validate diagnostic and prognostic tests for patients with recently diagnosed rheumatoid arthritis to predict joint damage and response to (DMARD) therapy.

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…

The effect of natalizumab treatment on functional adaptation in multiple sclerosis (MS)

The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…

An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.

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…

A MULTICENTER POSTMARKETING STUDY TO EVALUATE
THE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL IN
PREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®
(CERTOLIZUMAB PEGOL)

The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants.The secondary and exploratory objectives are to assess the…

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 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, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects

Primary objective:To demonstrate bioequivalence of GP2015 applied by an autoinjector (delta-GP2015_50) and a pre-filled syringe (PFS) as single subcutaneous injection of 50 mg to healthy adult male subjectsSecondary objectives- To study and compare…

A study investigating the biological availability of ALX-0061, a new drug in the treatment of rheumatoid arthritis, after subcutaneous and intravenous administration in healthy volunteers.

The purpose of the study is to investigate to what extent ALX-0061 is tolerated. It will also be investigated how quickly and to what extent ALX-0061 is absorbed and eliminated from the body (this is called pharmacokinetics), and how much of the…

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…

Effect of Tocilizumab on subclinical arterial inflammation and stiffness in patients with active rheumatoid arthritis (DAS28 > 3.2)

To investigate the effect of anti-IL6 therapy with tocilizumab on subclinical arterial inflammation (endothelial dysfunction) and stiffness in patients with treatment resistant rheumatoid arthritis at baseline and after 6 months treatment

Sandostatin therapy in sarcoidosis

Primary Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated. . Secondary Objective(s): To study the composite…