Phase 2
Completed N=100
Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00628095 ↗
Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12 — 33.96; 36.17 Percentage of participants — p=0.591
Summary
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12 |
33.96; 36.17 | 0.591 |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8 |
13.21; 25.53; 32.08; 38.30; 30.19; 29.79 | 0.941 |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% (ACR50) Response |
5.66; 6.38; 7.55; 8.51; 13.21; 12.77 | 0.989 |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% (ACR70) Response |
3.77; 0.00; 5.66; 4.26; 5.66; 0.00 | 0.121 |
| SECONDARY Number of Tender/Painful and Swollen Joints |
13.13; 14.45; 11.68; 12.45; 10.33; 12.26 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis |
53.74; 54.83; 48.04; 50.65; 42.15; 48.28 | — |
| SECONDARY Patient's Global Assessment of Arthritis |
56.91; 59.34; 50.43; 49.66; 42.94; 42.24 | — |
| SECONDARY Patient's Global Assessment of Arthritic Pain |
51.33; 60.13; 49.20; 51.51; 43.70; 48.43 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
1.26; 1.38; 1.15; 1.22; 1.06; 1.19 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
5.11; 5.22; 4.55; 4.84; 4.22; 4.48 | — |
| SECONDARY C-Reactive Protein (CRP) |
11.53; 9.22; 11.04; 9.23; 11.22; 8.97 | — |
| SECONDARY Incidence of Withdrawal Due to Lack of Efficacy |
0; 0; 0; 0; 0; 0 | 1.0000 |
| SECONDARY Time to Withdrawal Due to Lack of Efficacy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Active rheumatoid arthritis
- Incomplete response to methotrexate
Exclusion Criteria
- Must not be on biologic therapies
- No recent infections
Data sourced from ClinicalTrials.gov (NCT00628095). 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. Informational only — not medical advice.