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NCT ID: NCT02489227 Completed - Plaque Psoriasis Clinical Trials

Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

PsOsim
Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

NCT ID: NCT02484638 Terminated - Clinical trials for Hemophilia A With Inhibitors

Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors

Start date: July 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2 (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the best efficacy and safety in stopping acute bleeding events (this dose will be called the "population best dose"). The purpose of the final Part 3 (Repeated-dose part) is to confirm the efficacy and safety of the "population best dose" identified in Part 2. In Parts 2 and 3, subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie, when a bleeding event occurs), will keep an electronic diary, and will visit the center at monthly intervals. This study is expected to last for up to 16 months for the subjects participating in all 3 parts, and up to 9 months for the subjects participating in Part 3 only.

NCT ID: NCT02480153 Completed - Clinical trials for Rheumatoid Arthritis

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Start date: June 25, 2015
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

NCT ID: NCT02477839 Completed - Clinical trials for Epilepsy With Partial-onset Seizures

Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

Start date: June 5, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

NCT ID: NCT02472964 Completed - Breast Cancer Clinical Trials

Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca.

HERiTAge
Start date: July 2012
Phase: Phase 3
Study type: Interventional

A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane as first line therapy in patients with HER2-positive metastatic breast cancer.

NCT ID: NCT02472795 Completed - Clinical trials for Systemic Lupus Erythematosus

Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Start date: June 1, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

NCT ID: NCT02468791 Completed - Clinical trials for Rheumatoid Arthritis

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.

NCT ID: NCT02467868 Completed - Breast Neoplasms Clinical Trials

Efficacy and Safety Study With MYL-1401H and Neulasta

Start date: March 2015
Phase: Phase 3
Study type: Interventional

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

NCT ID: NCT02448680 Completed - Clinical trials for Hemophilia A With Inhibitors

A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa

PERSEPT2
Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years old).

NCT ID: NCT02435992 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Start date: June 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).