Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab
Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)
1 other identifier
interventional
50
1 country
1
Brief Summary
Aim of this study is to determine wether the macromolecular spectral characteristic of ulcerative colitis patients - measured by Physiological Intermolecular Modification Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 10, 2014
July 1, 2014
1.5 years
July 1, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response
Reduction of partial Mayo Score \> 2 points versus baseline
Week 14
Secondary Outcomes (2)
Calprotectin stool levels
Week 6
Calprotectin stool levels
Week 14
Other Outcomes (1)
molecular spectral range
Week 14
Study Arms (1)
Golimumab
OTHERGolimumab: Patients with body weight less than 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 50 mg every 4 weeks, thereafter // Patients with body weight greater than or equal to 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter
Interventions
Eligibility Criteria
You may qualify if:
- moderate to severe active ulcerative colitis
- qualified for initiating Golimumab therapy, i.e.inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance of medical contraindications to such therapies
- must be able and willing to provide written informed consent
- must have a negative tuberculosis screening or if inactive (latent) tuberculosis diagnosed anti-tuberculosis therapy to be started before initiation of Golimumab therapy in accordance with local recommendations
You may not qualify if:
- cancer
- type one diabetes
- current infection and/or inflammation other than related to ulcerative colitis
- autoimmune diseases
- any contraindications stated by Golimumab product label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kliniken im Naturpark Altmuehltal; Klinik Koesching
Kösching, 85092, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias G Breidert, MD
Naturpark Kliniken Altmuehltal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 10, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 10, 2014
Record last verified: 2014-07