Trial Outcomes & Findings for IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA (NCT NCT02451748)

NCT ID: NCT02451748

Last Updated: 2024-07-10

Results Overview

Expression of IL-7 and IL-7R mRNA levels measured by real-time RT-PCR.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline and 3 and 6 months
• Results posted on: 2024-07-10

Participant Flow

Only 10 patients were analyzed for IL-7 and IL-7R mRNA levels at onset, 3 months after Cimzia treatment and 6 months after Cimizia.

Participant milestones

Measure	DMARD's Responder and Non-Responder Individuals with rheumatoid arthritis (RA) receiving disease modifying anti-rheumatic drugs (DMARDs). Treating rheumatologists did not consistently measure DAS28\<2.6, therefore this group consisted of both responders and non-responders to DMARDs (instead of only non-responders as originally planned). Blood samples were collected only once at the participant's routine visit.	DMARD's Plus Cimzia (Certolizumab Pegol) Individuals with rheumatoid arthritis (RA) that did not respond to disease modifying anti-rheumatic drugs (DMARDs) were treated with DMARDs and Cimzia®. Cimzia® is an FDA approved drug and is a standard of care. In this group, blood samples were collected at study onset and 3 and 6 months after treatment with Cimzia at the patient's visit with the rheumatologists.
Overall Study STARTED	12	15
Overall Study Participants With Evaluable Data at Visit 1	0	10
Overall Study Participants With Evaluable Data at Visit 2	0	10
Overall Study Participants With Evaluable Data at Visit 3	0	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	DMARD's Responder and Non-Responder n=12 Participants Individuals with rheumatoid arthritis (RA) receiving disease modifying anti-rheumatic drugs (DMARDs). Treating rheumatologists did not consistently measure DAS28\<2.6, therefore this group consisted of both responders and non-responders to DMARDs (instead of only non-responders as originally planned). Blood samples were collected only once at the participant's routine visit.	DMARD's Plus Cimzia (Certolizumab Pegol) n=15 Participants Individuals with rheumatoid arthritis (RA) that did not respond to disease modifying anti-rheumatic drugs (DMARDs) were treated with DMARDs and Cimzia®. Cimzia® is an FDA approved drug and is a standard of care. In this group, blood samples were collected at study onset and 3 and 6 months after treatment with Cimzia at the patient's visit with the rheumatologists.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=12 Participants	12 Participants n=15 Participants	19 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=12 Participants	3 Participants n=15 Participants	8 Participants n=27 Participants
Sex: Female, Male Female	10 Participants n=12 Participants	12 Participants n=15 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=12 Participants	3 Participants n=15 Participants	5 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	15 participants n=15 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 3 and 6 months

Population: 10 at 3 months, 5 at 6 months for DMARD's plus Cimzia group

Expression of IL-7 and IL-7R mRNA levels measured by real-time RT-PCR.

Outcome measures

Measure	DMARD's Responder and Non-Responder IL-7 and IL-7 receptor at baseline	DMARD's Plus Cimzia (Certolizumab Pegol) n=10 Participants IL-7 and IL-7 receptor at 3 and 6 months
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 1 IL7	—	0.700 fold change vs housekeeping gene change Standard Error 0.132
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 1 IL7R	—	1.330 fold change vs housekeeping gene change Standard Error 0.315
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 2 IL7	—	0.777 fold change vs housekeeping gene change Standard Error 0.104
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 2 IL7R	—	1.460 fold change vs housekeeping gene change Standard Error 0.166
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 3 IL7	—	0.569 fold change vs housekeeping gene change Standard Error 0.264
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. Visit 3 IL7R	—	0.0163 fold change vs housekeeping gene change Standard Error 0.0157

Adverse Events

DMARD's Responder and Non-Responder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DMARD's Plus Cimzia (Certolizumab Pegol)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shiva Shahrara, PhD

University of Illinois at Chicago

Phone: 312-413-7529

Email: shahrara@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place