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NCT ID: NCT01684345 Terminated - Uveitis Clinical Trials

Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

EYEGUARD™-A
Start date: August 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

NCT ID: NCT01682512 Terminated - Clinical trials for Arthritis, Rheumatoid

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

Start date: September 5, 2012
Phase: Phase 3
Study type: Interventional

The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.

NCT ID: NCT01659658 Terminated - Clinical trials for Relapsed or Refractory Systemic Light Chain Amyloidosis

Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Start date: December 26, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

NCT ID: NCT01648465 Terminated - Clinical trials for Pancreatic Neuroendocrine Tumors

Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

Start date: August 6, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors.

NCT ID: NCT01633060 Terminated - Clinical trials for Metastatic Breast Cancer

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

BELLE-3
Start date: October 3, 2012
Phase: Phase 3
Study type: Interventional

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

NCT ID: NCT01616043 Terminated - Clinical trials for Full-thickness Skin Loss Due to Burn, Unspecified Site

Glyaderm Clinical Evaluation Multicenter Study

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The healing of full thickness skin defects treated with a split thickness skin graft (STSG) is frequently associated with excessive scarring and contraction. The psychological burden of poor cosmesis of these scarred regions as well as functional problems due to skin tightness and decreased joint mobility cause a very significant morbidity in these patients. Application of a dermal substitute underneath the split skin may improve the quality of the scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this substitute it will contribute to a long term improvement of pliability and function and a better esthetic outcome. The main objective is to evaluate the difference in scar quality, after skin restoration of full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary objectives are: to evaluate the percentage of Glyaderm® take before application of autografts, to compare healing time and percentage of autograft survival and bacterial load in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct a concurrent cost-effectiveness and health related quality of life study (i.e. cost utility analysis). The study is an interventional, prospective, randomized and controlled interactive web based, study in a multicentre setting. Patients with full thickness burn wounds or full thickness skin defects will be evaluated before enrolment. A total of 120 patients will be included. All included patients will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm® group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin STSG. In the control group, the wounds are immediately covered with a thin STSG. Up to one year after complete wound closure, patients are followed-up for scar evaluation and quality of life.

NCT ID: NCT01609036 Terminated - Clinical trials for Lymphoma, Follicular

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

Start date: October 2012
Phase: N/A
Study type: Observational

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years

NCT ID: NCT01578785 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

GLOW
Start date: March 2012
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

NCT ID: NCT01571635 Terminated - Clinical trials for Beta Thalassemia Major

Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.

Start date: October 10, 2012
Phase: Phase 2
Study type: Interventional

Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

NCT ID: NCT01536418 Terminated - Crohn's Disease Clinical Trials

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

SHIELD-4
Start date: November 11, 2011
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.