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Rheumatoid Arthritis clinical trials

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NCT ID: NCT00385528 Completed - Diabetes Clinical Trials

Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial

Start date: November 2002
Phase: Phase 4
Study type: Interventional

Background: somatic patients with psychiatric co-morbidities are a major challenge for the health care system. This study evaluated a psychiatric intervention targeted at the complex medically ill identified by means of the INTERMED, an instrument to assess case complexity. Methods: of 885 rheumatology inpatients and diabetes outpatients who were assessed for eligibility, 247 were identified as complex (INTERMED score > 20) and randomized to the intervention (N=125, 84 rheumatology and 41 diabetes patients) or care as usual (N=122, 78 rheumatology and 44 diabetes patients). Intervention consisted of counseling by a psychiatric nurse, referral to a liaison psychiatrist, or a multidisciplinary case conference. Baseline and follow up at months 3, 6, 9 and 12 measured prevalence of major depression (MINI), depressive symptoms (CES-D), physical and mental health (SF-36), quality of life (EuroQol), hospitalizations (rheumatology patients) and HbA1c levels (diabetic patients).

NCT ID: NCT00380601 Completed - Clinical trials for Rheumatoid Arthritis

PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

Start date: May 2006
Phase: Phase 3
Study type: Interventional

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

NCT ID: NCT00372177 Completed - Clinical trials for Rheumatoid Arthritis

The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only a scheme with different symptoms is used to diagnose rheumatoid arthritis, often only by probability. Due to the fact that effective disease modifying pharmacological treatment is available and should be started early in established cases of RA, in combination with the adverse effect potential of these substances (e.g. methotrexate), a fast reliable diagnostic tool to diagnose rheumatoid arthritis would be highly appreciated by the medical community and the patients. Furthermore, for invasive treatments (surgery, puncture), an imaging method to display the activity pattern in different joints would be a major advantage. For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis, up to now, radiological measurements of the destruction process of the joints are used. This method has the disadvantage that it is time consuming insofar as changes in the radiological images must occur. It allows only an evaluation if the joints are destructed (which should be excluded by the new therapy regimen). Again, a quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated.

NCT ID: NCT00369928 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

Start date: August 2006
Phase: Phase 2
Study type: Interventional

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

NCT ID: NCT00369473 Completed - Clinical trials for Rheumatoid Arthritis

Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

Start date: September 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

NCT ID: NCT00369187 Completed - Clinical trials for Rheumatoid Arthritis

Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

Start date: July 2006
Phase: Phase 4
Study type: Interventional

This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.

NCT ID: NCT00367211 Completed - Clinical trials for Rheumatoid Arthritis

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.

NCT ID: NCT00365404 Completed - Clinical trials for Rheumatoid Arthritis

Activity, Rheumatoid and Osteoarthritis, and Weight Management

Start date: October 2003
Phase: N/A
Study type: Interventional

The purpose of the study was to implement well-developed guidelines for arthritis management beyond acute medical management to independent community living by modifying existing weight management and physical activity promotion programs for people with disabling arthritis. Our hypotheses were: 1. Existing individual, health care system, and community strategies to promote physical activity and weight management can effectively be modified and expanded to include those with debilitating joint diseases. 2. People with inflammatory joint disease can have healthy physical activity levels and weight at home and in the community. 3. The effect of these interventions will be higher quality of life, lower depression rates, modest pain levels, and functional independence.

NCT ID: NCT00365001 Completed - Clinical trials for Rheumatoid Arthritis

A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Start date: n/a
Phase: Phase 1
Study type: Interventional

This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

NCT ID: NCT00364728 Recruiting - Clinical trials for Rheumatoid Arthritis

Efferocytosis and Genomic Polymorphism in Autoimmune Diseases

Start date: January 2006
Phase: N/A
Study type: Observational

Over the past few years, growing evidences revealed that clearance of apoptotic cells by phagocytosis can result in powerful anti-inflammatory and immunosuppressive effects. In vivo, apoptotic cells are cleared rapidly by neighboring cells, macrophages and related scavengers. Defective clearance of apoptotic cells has been linked closely to autoimmunity and persistent inflammatory disease. Several phagocytic receptors, bridging molecules produced by phagocytes and 'eat-me' signals on apoptotic cells are coordinately involved in mediating clearance of apoptotic cells. Complement receptors (CR3, CR4), collection, CD14, CD36 (Class B scavenger receptor), class A scavenger receptor, asialoprotein receptor, Mer receptor kinase were reported to recognize apoptotic cells. The best characterized system for clearance of apoptotic cells is the recognition of phosphatidylserine (PS) on apoptotic cells by phosphatidylserine receptor (PSR). Milk fat globule- epidermal growth factor 8 (MFG-E8) is an opsonin that bridges phagocytes (by interacting with α vβ3, αvβ5 integrins via RGD motif) and apoptotic cells (by binding PS through Factor V/VIII-C domain). Activated macrophages produce and secret MFG-E8. MFG-E8 is a critical component in PSR-mediated phagocytosis of apoptotic cells. The dominant negative mutant MFG-E8, D89E, that carried a mutated RGD motif inhibited phagocytosis of apoptotic cells in vitro. Injection of D89E into wild type mice induced autoantibodies and IgG deposition on glomeruli. Macrophages from MFG-E8 deficiency (MFG-E8-/-) mice were impaired in engulfment of apoptotic cells, which can be restored by adding recombinant MFG-E8. The female MFG-E8-/- mice spontaneously produced high titer of autoantibodies and developed lupus-like glomerulonephritis at the age of week 40. Defective clearance of apoptotic cells is closely related to development of autoimmunity. In the past 4 years, a growing number of molecules were recognized as receptors for the PS exposed on the apoptotic cells. These molecules were capable of mediating phagocytic clearance, rendering anti-inflammatory cytokines in the phagocytes, and modulating T cell responses. The specific aim of this proposal is to study genetic polymorphism in MFG-E8, PSR and other factors implicated in phagocytic clearance of apoptotic cells among Taiwanese. By comparing the polymorphism between patients with autoimmune disease (SLE or RA) and healthy control subjects, we will investigate if genetic variations among individuals of genes encoding proteins involved in clearance of apoptotic cells contribute to the pathogenesis of systemic autoimmune diseases SLE and RA.