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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…

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.

Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial

This study has been transitioned to CTIS with ID 2023-505877-34-00 check the CTIS register for the current data. To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of…

Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Primary objective: To show a meaningful reduction in progression of DD with the application of radiotherapy both in the early stages as well as following local treatment in the later stages.Secondary objectives: 1. Report physician graded toxicity…

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension
Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus.

This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data. The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of litifilimab in participants with…

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…