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A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…

A randomised, double-blind, placebo-controlled,
multicentre prospective dose-finding Phase II/III study
with atacicept given subcutaneously to subjects having
recently experienced a flare of systemic lupus
erythematosus (SLE)

PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…

Double blind, placebo controlled study Tacrolimus versus Emmolient in localized scleroderma

The primary objective of this study is to assess whether tacrolimus is effective for the treatment of morphea.

A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION

Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…

A randomised multicentre, prospective, double blind phase III trial investigating the effect of radiotherapy on patients with Ledderhose disease.

The aim of this study is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.

A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren*s Disease

Primary objective: To determine if injection with the optimal dose of adalimumab (40mg) is superior to placebo injection of normal saline in controlling disease progression in patients with early Dupuytren*s disease.Secondary objectives: * To…

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

The aim of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin in preventing new arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

This study has been transitioned to CTIS with ID 2023-505696-74-00 check the CTIS register for the current data. The primary objective of this study is to demonstrate efficacy of BIIB059compared with placebo in participants with active systemic…

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis

The primary objective of this study is to evaluate in patients suffering from diffuse cutaneous SSc (DcSSc) the effect of 800mg and 1200mg IVA337 daily on the skin compared to placebo. The modified Rodnan Skin Score (MRSS) will be used to determine…

Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomised double-blind placebo-controlled trial.

Objective 1: analyze the effect of short-term treatment with high dose glucocorticoids on vasculopathic abnormalities as measured by NCM in patients with very early SSc.Objective 2: investigate the effects of glucocorticoids on signs and symptoms of…