Biologics And Clinical Immunology Cohort at Sinai
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
The study team plans to establish a bioregistry of patients receiving biologic therapy as part of their standard treatment at the Mount Sinai Therapeutic Infusion Center and affiliated practices. The study team will to apply state-of-the-art approaches to assessing and predicting immunological and clinical responses associated with these standards and prescribed treatments. The approach is twofold. The first component is to establish a robust and flexible biorepository and database that includes demographic, immunologic, exposure and clinical records, and can facilitate research across disciplines, and across other registries affiliated with Mount Sinai. The second component is to address specific key research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment. Most patients will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient Sinai affiliated clinical practices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12 years and up.
Able to provide informed consent.
Medical care at Mount Sinai.
Receiving a biologic medication or immune modulator at Mount Sinai, or considered an appropriate negative control or comparison participant by the study team.
Disqualifiers
None
Trial population
Patients undergoing treatment at Mount Sinai Therapeutic Infusion Center will be one major source of participants. Active recruitment will focus on patients new to the Infusion Center. These patients and potential subjects will be densified 1-2 weeks in advance following review of the electronic medical record's schedule by a research study coordinator or other investigator. The primary or referring clinical team, or the current Infusion Center medical team, will let the patient know that a study is available, and if the patient is agreeable, that the research team will contact them.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Biologics and Clinical Immunology Registry
Establish a bioregistry of patients receiving biologic therapy as part of their standard treatment at the Mount Sinai Therapeutic Infusion Center and affiliated practices. The approach is twofold. The first component is to establish a robust and flexible biorepository and database that includes demographic, immunologic, exposure and clinical records, and can facilitate research across disciplines, and across other registries affiliated with Mount Sinai. The second component is to address specific key research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment.
Time frame
3 yearsSecondary outcomes
1
Asthma Control Questionnaire (ACQ)
For patients with asthma. The Asthma Control Questionnaire (ACQ) assess asthma beliefs about asthma control. The ACQ is a 7-item instrument, full scale from 0-6, higher score indicates more impairment.
Time frame
Up to 3 years2
Multidimensional Health Assessment Questionnaire (MDHAQ)
For patients with rheumatological disorders. Full scale from 0-3, higher score indicates poorer health outcomes.
Time frame
Up to 3 years3
Clinical Disease Activity Index CDAI) - need information
For patients with rheumatologically disorders who are recruited initially in their rheumatology physician office. Full scale from 0 to 76, with higher score indicating poorer health outcomes.
Time frame
Up to 3 years4
Birmingham Vasculitis Activity Score (BVA)
For patients with vasculitis. Full scale from 0 to 63, with higher score indicating poorer health outcomes.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov