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NCT ID: NCT03259529 Completed - Clinical trials for Diffuse Large B Cell Lymphoma

Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL

BeGeRN
Start date: March 27, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.

NCT ID: NCT03259074 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

SURPASS
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

NCT ID: NCT03257267 Completed - Clinical trials for Squamous Cell Carcinoma (SCC)

Study of Cemiplimab in Adults With Cervical Cancer

Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: - To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy - To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy - To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

NCT ID: NCT03255278 Completed - Tuberculosis Clinical Trials

Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.

GamTBvac
Start date: January 15, 2017
Phase: Phase 1
Study type: Interventional

The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years.

NCT ID: NCT03253796 Completed - Spondyloarthritis Clinical Trials

Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)

Start date: November 7, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

NCT ID: NCT03252587 Completed - Clinical trials for Systemic Lupus Erythematosus

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Start date: September 21, 2017
Phase: Phase 2
Study type: Interventional

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

NCT ID: NCT03251482 Completed - Clinical trials for VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

TEXT-TKR
Start date: November 13, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).

NCT ID: NCT03249714 Completed - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Start date: March 15, 2018
Phase: Phase 2
Study type: Interventional

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

NCT ID: NCT03249376 Completed - Bipolar Depression Clinical Trials

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

NCT ID: NCT03248531 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Start date: September 22, 2017
Phase: Phase 2
Study type: Interventional

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.