Phase 4
N=27
IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02451748 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: 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. — 0.700; 1.330; 0.777; 1.460 fold change vs housekeeping gene change — p=0.5378
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lab Work (Other); Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg) (Drug); Certolizumab pegol (CDP870, tradename Cimzia) (Drug); Hydroxychloroquine (Drug); Sulfasalazine (Drug); Medrol (Drug); Prednisone (Drug); Triamcinolone (Drug); Naproxen (Drug); Leflunomide (Drug); Methotrexate (Drug); humira (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.700; 1.330; 0.777; 1.460; 0.569; 0.0163 | 0.5378 |
Summary
The purpose of the study is to better understand the factors present in the cells of inflamed joints of patients with arthritis that may cause rheumatoid arthritis. Knowledge gained from this study may lead to new and better therapies for arthritis.
Eligibility Criteria
Inclusion Criteria
- Must meet 1987 Revised Criteria for the Classification of Rheumatoid Arthritis defined as the diagnosis of the referring physician.
- Persistent knee swelling (>ARA grade 2) for 2 weeks, and no recent intra-articular corticosteroid injection.
- Age 18 years and older.
- Must be on Disease modifying anti rheumatic drugs (DMARDs) such as methotrexate, plaquenil and/or prednisone.
Exclusion Criteria
- Patients having received intra-articular corticosteroid joint injection within the last 2-4 weeks.
- Patients with active systemic or joint infections.
- Women who are pregnant (pregnancy status will be self-reported)
- Patients under 18 years of age
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT02451748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.