Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis
Eligible Conditions
- Arthritis
- Musculoskeletal Diseases
- Rheumatoid Arthritis
- Rheumatic Diseases
- Joint Diseases
- Connective Tissue Diseases
- Immune System Diseases
- Autoimmune Diseases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Week 12
Baseline to Week 12
Percentage of Participants Achieving ACR50 or ACR70
Percentage of Participants Achieving American College of Rheumatology (ACR)20
Pharmacokinetics (PK): Observed Trough Drug Concentration
Baseline, Week 12
Change from Baseline in CDAI
Change from Baseline in DAS28-hsCRP
Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
Week 12
Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Placebo
1 of 4
Peresolimab Dose 2
1 of 4
Peresolimab Dose 1
1 of 4
Peresolimab Dose 3
1 of 4
Active Control
Experimental Treatment
420 Total Participants · 4 Treatment Groups
Primary Treatment: Peresolimab · Has Placebo Group · Phase 2
Peresolimab Dose 2
Drug
Experimental Group · 1 Intervention: Peresolimab · Intervention Types: DrugPeresolimab Dose 1
Drug
Experimental Group · 1 Intervention: Peresolimab · Intervention Types: DrugPeresolimab Dose 3
Drug
Experimental Group · 1 Intervention: Peresolimab · Intervention Types: DrugPlacebo
Drug
ActiveComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Closest Location: Health Research of Oklahoma · Oklahoma City, OK
2007First Recorded Clinical Trial
26 TrialsResearching Arthritis
30 CompletedClinical Trials
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,428 Previous Clinical Trials
3,117,824 Total Patients Enrolled
41 Trials studying Arthritis
22,590 Patients Enrolled for Arthritis
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,231 Previous Clinical Trials
364,439 Total Patients Enrolled
26 Trials studying Arthritis
15,193 Patients Enrolled for Arthritis
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
You have moderate-to-severely active RA.
You have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD ( tsDMARD) treatment.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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