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NCT ID: NCT01754727 Completed - Clinical trials for Ankylosing Spondylitis

Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

IDEA
Start date: December 2012
Phase: N/A
Study type: Observational

Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to the health care system as well as the whole society. The introduction of biologic therapy, though allowing for superior clinical and work productivity outcomes, has significantly increased direct medical costs of AS. Therefore it is important to weight the benefits against the costs to gain a basis for decisions on health care resource allocation. Due to differences in the health care systems, health insurance and general country settings, health economic data cannot be generalized across countries. Such data is generally lacking in Central and Eastern European countries, especially in the field of rheumatology. This study will evaluate selected health care resource utilization and productivity losses in patients with AS during and before the treatment with adalimumab in clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance, hospitalizations and sick leave, which could be influenced by relatively short-term adalimumab therapy, will be taken into account, and in relation to treatment response. There is no published data on the impact of adalimumab therapy on hospitalizations and outpatient attendance in patients with AS. Further, data on health care resource utilization and sick leave before and during adalimumab therapy could be translated into financial cost estimates (potential cost savings) by each participating country, based on their own country specific cost per resource.

NCT ID: NCT01752855 Completed - Clinical trials for Rheumatoid Arthritis

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

Start date: December 2012
Phase: Phase 2
Study type: Interventional

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

NCT ID: NCT01751152 Completed - Inflammation Clinical Trials

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

Start date: February 2013
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.

NCT ID: NCT01742052 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Dose-finding Study of MT-1303

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters - To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.

NCT ID: NCT01741519 Completed - Healthy Clinical Trials

Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The study will compare the pharmacokinetics (PK), safety and tolerability of long-term infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and adverse events (AEs).

NCT ID: NCT01738035 Completed - Clinical trials for Primary IgA Nephropathy

The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

NEFIGAN
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).

NCT ID: NCT01732835 Completed - Clinical trials for Aortic Insufficiency

The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

Start date: December 2012
Phase: N/A
Study type: Interventional

This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.

NCT ID: NCT01731249 Completed - Allergic Rhinitis Clinical Trials

Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

NCT ID: NCT01726413 Completed - Clinical trials for Painful Diabetic Peripheral Neuropathy

A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Start date: November 2012
Phase: Phase 2
Study type: Interventional

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

NCT ID: NCT01723982 Completed - Infertility Clinical Trials

Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

BASIC
Start date: November 2012
Phase: Phase 2
Study type: Interventional

This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment