Phase 4
Completed N=132
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01443364 ↗Enrolled (actual)
132
Serious AEs
12.1%
Results posted
Mar 2016
Primary outcomePrimary: The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 — 69.1 percentage of subjects
◆ Published Evidence
Emerging
18citations · ~2 / year
Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study.
Summary
The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.
Linked Publications
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Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 |
69.1 | — |
| PRIMARY The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52 |
69.8 | — |
| PRIMARY The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52 |
65.2 | — |
| PRIMARY The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52 |
66.7 | — |
| PRIMARY The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52 |
64.9 | — |
| PRIMARY The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52 |
55.8 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 52 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 36 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 24 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 12 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 8 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 6 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 4 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 2 |
-1.0 | — |
| SECONDARY Change From Baseline in the Synovial Fluid and Proliferation at Week 1 |
0.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 52 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 36 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 24 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 12 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 8 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 6 |
-1.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 4 |
-0.5 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 2 |
0.0 | — |
| SECONDARY Change From Baseline in the Doppler Signal and Blood Flow at Week 1 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 52 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 36 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 24 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 12 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 8 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 6 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 4 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 2 |
0.0 | — |
| SECONDARY Change From Baseline in the Cartilage Damage at Week 1 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 52 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 36 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 24 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 12 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 8 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 6 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 4 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 2 |
0.0 | — |
| SECONDARY Change From Baseline in the Bone Erosion at Week 1 |
0.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 |
-3.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 |
-3.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 |
-3.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 |
-3.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 |
-3.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 |
-2.5 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 |
-2.5 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 |
-2.0 | — |
| SECONDARY Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 |
-1.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 |
-2.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 |
-2.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 |
-1.5 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 |
-2.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 |
-2.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 |
-2.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 |
-1.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 |
-1.0 | — |
| SECONDARY Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 |
-1.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 52 |
5.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 36 |
5.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 24 |
5.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 12 |
5.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 8 |
5.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 6 |
6.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 4 |
6.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 2 |
7.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 1 |
7.0 | — |
| SECONDARY Synovial Fluid and Proliferation at Week 0 |
8.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 52 |
0.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 36 |
0.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 24 |
0.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 12 |
0.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 8 |
0.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 6 |
0.5 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 4 |
2.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 2 |
1.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 1 |
1.0 | — |
| SECONDARY Doppler Signal and Blood Flow at Week 0 |
2.0 | — |
| SECONDARY Cartilage Damage at Week 52 |
4.0 | — |
| SECONDARY Cartilage Damage at Week 36 |
5.0 | — |
| SECONDARY Cartilage Damage at Week 24 |
4.5 | — |
| SECONDARY Cartilage Damage at Week 12 |
5.0 | — |
| SECONDARY Cartilage Damage at Week 8 |
4.5 | — |
| SECONDARY Cartilage Damage at Week 6 |
4.0 | — |
| SECONDARY Cartilage Damage at Week 4 |
4.0 | — |
| SECONDARY Cartilage Damage at Week 2 |
4.0 | — |
| SECONDARY Cartilage Damage at Week 1 |
5.0 | — |
| SECONDARY Cartilage Damage at Week 0 |
6.0 | — |
| SECONDARY Bone Erosion at Week 52 |
2.0 | — |
| SECONDARY Bone Erosion at Week 36 |
2.0 | — |
| SECONDARY Bone Erosion at Week 24 |
2.0 | — |
| SECONDARY Bone Erosion at Week 12 |
2.0 | — |
| SECONDARY Bone Erosion at Week 8 |
2.0 | — |
| SECONDARY Bone Erosion at Week 6 |
2.0 | — |
| SECONDARY Bone Erosion at Week 4 |
2.0 | — |
| SECONDARY Bone Erosion at Week 2 |
2.0 | — |
| SECONDARY Bone Erosion at Week 1 |
2.0 | — |
| SECONDARY Bone Erosion at Week 0 |
2.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 |
5.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 |
6.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 |
6.5 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 |
7.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 |
6.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 |
7.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 |
8.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 |
8.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 |
8.0 | — |
| SECONDARY Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 |
10.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 |
7.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 |
8.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 |
10.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 |
9.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 |
9.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 |
8.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 |
8.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 |
10.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 |
10.0 | — |
| SECONDARY Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0 |
12.0 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
- positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
- active RA disease
- subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
- subject is naïve to RA related biologics
Exclusion Criteria
- a diagnosis of any other inflammatory arthritis
- history of infected joint prosthesis, or other significant infection
- known Tuberculosis (TB) disease or high risk of acquiring TB infection
Data sourced from ClinicalTrials.gov (NCT01443364) and the linked publication. 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.