Phase 4
Completed N=333
Dosing Flexibility Study in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00580840 ↗Enrolled (actual)
333
Serious AEs
4.6%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 — 65.2; 67.1; 44.9 percentage of subjects
Summary
During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 |
65.2; 67.1; 44.9 | — |
| SECONDARY Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients |
61.3 | — |
| SECONDARY Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients |
37.8 | — |
| SECONDARY Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients |
16.2 | — |
| SECONDARY Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients |
-2.3 | — |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients |
-24.1 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients |
-23.3 | — |
| SECONDARY DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients |
17.7 | — |
| SECONDARY SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients |
15.9 | — |
| SECONDARY CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients |
17.1 | — |
| SECONDARY Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients |
0.5 | — |
| SECONDARY Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients |
-0.5 | — |
| SECONDARY Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18 |
52.2; 50.0; 30.4 | — |
| SECONDARY Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18 |
37.7; 30.0; 15.9 | — |
| SECONDARY Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18 |
-3.04; -2.83; -1.65 | — |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18 |
-30.46; -28.15; -17.35 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18 |
-29.06; -27.14; -17.03 | — |
| SECONDARY DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18 |
29.0; 18.6; 5.8 | — |
| SECONDARY SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18 |
29.0; 17.1; 13.0 | — |
| SECONDARY CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18 |
27.5; 21.4; 15.9 | — |
| SECONDARY Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18 |
0.44; 0.48; 0.82 | — |
| SECONDARY Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18 |
-0.64; -0.72; -0.38 | — |
| SECONDARY Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18 |
-2.39; -3.03; -1.33 | — |
| SECONDARY Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
8.39; 9.07; 4.09 | — |
| SECONDARY Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
9.80; 11.06; 7.14 | — |
| SECONDARY Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
12.95; 11.28; 6.12 | — |
| SECONDARY Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
5.46; 5.51; 3.16 | — |
| SECONDARY Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
9.88; 11.53; 5.47 | — |
| SECONDARY Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
8.87; 10.03; 6.42 | — |
| SECONDARY Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
6.86; 8.86; 5.86 | — |
| SECONDARY Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 |
5.38; 7.44; 4.13 | — |
| SECONDARY Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18 |
10.54; 9.65; 5.09 | — |
| SECONDARY Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18 |
5.51; 8.59; 4.90 | — |
| SECONDARY Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18 |
-36.41; -34.33; -17.47 | — |
| SECONDARY Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18 |
-35.58; -33.07; -16.37 | — |
| SECONDARY Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18. |
NA; NA; 98.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months
Exclusion Criteria
- All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial
Data sourced from ClinicalTrials.gov (NCT00580840). 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.