Phase 3
Completed N=1,063
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00717236 ↗Enrolled (actual)
1,063
Serious AEs
7.0%
Results posted
May 2011
Primary outcomePrimary: American College of Rheumatology 20% (ACR20) Response at Week 12 — 51.1; 25.9 percentage of subjects
Summary
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology 20% (ACR20) Response at Week 12 |
51.1; 25.9 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use. |
52.5; 28.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use. |
48.1; 21.7 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use |
47.2; 27.5 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use |
53.5; 25.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years |
50.0; 30.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years. |
51.5; 24.7 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response at Week 12 |
26.6; 9.9 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response at Week 12. |
12.9; 2.8 | — |
| SECONDARY Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12 |
-1.70; -0.84 | — |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 |
-19.66; -10.78 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 |
-18.96; -10.93 | — |
| SECONDARY DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12 |
16.0; 5.7 | — |
| SECONDARY SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12 |
7.8; 1.9 | — |
| SECONDARY CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12 |
8.3; 1.9 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Week 12 |
-7.4; -4.5 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Week 12 |
-6.4; -3.6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 |
-0.38; -0.19 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Week 12 |
0.55; 1.05 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12 |
-22.1; -10.7 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12 |
-21.5; -10.1 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12 |
-31.2; -19.0 | — |
| SECONDARY Time to Sustained American College of Rheumatology 20% (ACR20) Response |
40.4; 13.2 | — |
| SECONDARY European League Against Rheumatism (EULAR) Response at Week 12 |
28.9; 10.4; 44.5; 37.3; 26.6; 52.4 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 28 |
58.5 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response at Week 28 |
35.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response at Week 28 |
17.4 | — |
| SECONDARY Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28 |
-1.94 | — |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28 |
-22.35 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28 |
-21.66 | — |
| SECONDARY DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28 |
22.6 | — |
| SECONDARY SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28 |
11.4 | — |
| SECONDARY CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28 |
12.1 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Week 28 |
-8.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Week 28 |
-7.2 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28 |
-0.46 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Week 28 |
0.59 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28 |
-23.1 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28 |
-23.0 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28 |
-35.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patient with established moderate to severe rheumatoid arthritis
Exclusion Criteria
- All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
Data sourced from ClinicalTrials.gov (NCT00717236). 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.