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Arthritis clinical trials

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NCT ID: NCT01947465 Completed - Clinical trials for Arthritis, Rheumatoid

Immunogenicity and Safety of Vaccinations in Immunocompromised Persons

Start date: October 2013
Phase: N/A
Study type: Observational

Backgound and relevance of the project: Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of contracting infections. The increased risk can be attributed to the immunological disorder itself, as well as to the immunosuppressive treatment. Vaccination against many infections is recommended in this patient group. However, the immunogenicity of vaccines may be reduced and may also be influenced by the administered treatment. Potential reactivation of the underlying disease triggered by vaccination is another important concern. From the patients' and public health perspectives, an important task of physicians is giving advice on vaccines. Completing this task is often difficult, because data on the immunogenicity and safety of vaccines in these patient groups are scarce, especially with regard to treatment with new immunosuppressive medications, such as biological agents. Lastly and importantly, due to new therapeutic options, health among AIIRD patients has considerably improved and an increasing number of patients undertake overseas travel activities requiring additional vaccinations. In this context, reliable advice with regard to vaccinations is almost impossible, because for most travel vaccinations the immunogenicity and safety profile is unknown. Research addressing the immunogenicity and safety of vaccines in different autoimmune inflammatory diseases treated with different immunosuppressive medications is urgently needed to allow giving evidence based vaccine advice. In this observational study the immunogenicity and safety of tetanus booster and hepatitis A vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a function of the underlying disease and the possible influence of commonly used immunosuppressive drugs on the immune response will be studied. Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of the most frequently recommended vaccinations, and the effect of a booster vaccination can be addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their importance, only very limited data are available for tetanus and hepatitis A vaccine in this patient group. By focusing on these vaccines the study will lead the way to the evaluation of further vaccines. The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as immunogenic and safe in AIIRD patients as in healthy controls.

NCT ID: NCT01942174 Completed - Clinical trials for Rheumatoid Arthritis

VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

VACIMRA
Start date: September 27, 2013
Phase: Phase 3
Study type: Interventional

To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.

NCT ID: NCT01941433 Completed - Clinical trials for Rheumatoid Arthritis

Arthritis Health Journal Proof of Concept Study

AHJ
Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.

NCT ID: NCT01941095 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Start date: November 20, 2013
Phase: Phase 3
Study type: Interventional

This Phase IIIb, multicenter, open label, single arm study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab as monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active rheumatoid arthritis who are either naïve to or have an inadequate response to prior non-biologic or/and biologic DMARDs. The anticipated time on study treatment is 52 weeks. Those participants who will complete the 60-week study period and have achieved Disease Activity Score 28 (DAS28) remission or a good European League Against Rheumatism (EULAR) response at 52 weeks will be eligible to enter the extension phase until tocilizumab is commercially available and reimbursed in Greece.

NCT ID: NCT01936181 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

NCT ID: NCT01932372 Completed - Clinical trials for Rheumatoid Arthritis

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Start date: July 26, 2013
Phase:
Study type: Observational

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice. 1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2) Long-term safety (particularly, malignant tumors and serious infections) and efficacy Occurrences of malignant tumors and serious infections will be compared with a control group.

NCT ID: NCT01931644 Completed - Breast Cancer Clinical Trials

At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

Start date: July 2013
Phase:
Study type: Observational

We are the missing link in clinical trials, connecting patients and researchers seamlessly and conveniently using a mobile health platform to advance medical research. We make it easy for patients to contribute to research for medical conditions that matter most to them, regardless of their location or ability to travel.

NCT ID: NCT01927263 Completed - Clinical trials for Rheumatoid Arthritis

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

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

The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.

NCT ID: NCT01925768 Completed - Psoriatic Arthritis Clinical Trials

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Start date: September 4, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

NCT ID: NCT01925157 Completed - Clinical trials for Rheumatoid Arthritis

A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of the study drug known as LY3090106 in healthy participants and in participants with RA who are having an inadequate response to methotrexate (MTX). The study will investigate how the body processes the study drug and how the study drug affects the body. The study will last about 3 months for each participant.