CLINICAL TRIALS PROFILE FOR SIMPONI
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All Clinical Trials for SIMPONI
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01212653 ↗ | Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS) | Completed | Chinese University of Hong Kong | Phase 4 | 2010-10-01 | 1. To determine the effect of Golimumab treatment on the number and function of Endothelial Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a possible mechanism for the effect of this treatment on endothelial function. 2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness, vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave velocity (PWV) and Augmentation index (AIx). 3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS) patients according to ASAS response criteria at month 3, 6 and 12. 4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing Spondylitis(AS) patients, using clinic-base data. |
| NCT01258777 ↗ | A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects | Completed | Centocor, Inc. | Phase 1 | 2010-10-01 | The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males. |
| NCT01288157 ↗ | A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects | Completed | Centocor, Inc. | Phase 1 | 2010-09-01 | The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants. |
| NCT01313858 ↗ | A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) | Completed | Merck Sharp & Dohme Corp. | 2010-04-01 | This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters. | |
| NCT01526174 ↗ | Intratympanic Injection for Autoimmune Inner Ear Disease | Terminated | Janssen Services, LLC | Phase 1/Phase 2 | 2012-03-01 | The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab. |
| NCT01526174 ↗ | Intratympanic Injection for Autoimmune Inner Ear Disease | Terminated | House Research Institute | Phase 1/Phase 2 | 2012-03-01 | The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab. |
| NCT01548768 ↗ | RHYTHM (Formerly Escape II Myocardium) | Completed | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Phase 4 | 2011-10-10 | For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls. For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care. The investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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