Phase 2
Completed N=302
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00383188 ↗
Enrolled (actual)
302
Serious AEs
5.0%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12 — 39.13; 41.89; 40.91; 40.00 percentage of participants — p=0.3131
Summary
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12 |
39.13; 41.89; 40.91; 40.00; 31.08 | 0.3131 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 |
14.93; 21.13; 27.91; 15.38; 13.89; 30.43 | 0.8619 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 |
1.49; 1.41; 4.65; 5.13; 0.00; 5.80 | 0.2982 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | 0.000 sig |
| SECONDARY Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 |
-2.486; -3.409; -4.285; -2.948; -2.098; -4.291 | 0.7053 |
| SECONDARY Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 |
-2.341; -2.738; -3.224; -2.328; -1.654; -3.847 | 0.4385 |
| SECONDARY Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 |
-9.289; -16.67; -19.22; -17.62; -6.486; -16.50 | 0.4943 |
| SECONDARY Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 |
-8.160; -19.61; -16.70; -12.53; -5.164; -13.66 | 0.4493 |
| SECONDARY Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 |
-6.612; -10.83; -14.92; -8.898; -5.203; -15.87 | 0.6733 |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 |
-4.785; -10.92; -12.87; -12.06; 4.198; -1.077 | 0.0447 sig |
| SECONDARY Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 |
-0.505; -0.837; -0.928; -0.791; -0.237; -0.743 | 0.1540 |
| SECONDARY Number of Participants Who Withdrew From Study Due to Lack of Efficacy |
9; 3; 3; 2; 6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 |
-0.166; -0.323; -0.291; -0.144; -0.046; -0.286 | 0.1857 |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 |
-0.671; -1.140; -1.190; -0.926; -0.083; -0.929 | 0.0815 |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 |
2.374; 3.509; 5.778; 2.818; 1.582; 2.857 | 0.4693 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
38; 47; 31; 33; 42; 2 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
68; 72; 43; 40; 74 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
4; 6; 4; 7; 8; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
65; 58; 39; 32; 68; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Physical Examination Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State |
5.4; 30.8; 51.3; 79.4 | — |
| SECONDARY Number of Participants With Concomitant Medications |
69; 73; 44; 40; 74 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with RA and has failed at least 1 DMARD therapy
Exclusion Criteria
- Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.
Data sourced from ClinicalTrials.gov (NCT00383188). 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.