Phase 3
Completed N=188
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02378506 ↗
Enrolled (actual)
188
Serious AEs
4.8%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12 — 1.9 percentage of participants
◆ Published Evidence
Emerging
1citation · ~0 / year
A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis.
Summary
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
Linked Publications
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A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12 |
1.9 | — |
| PRIMARY Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24 |
2.9 | — |
| PRIMARY Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment |
4.5 | — |
| SECONDARY Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment |
0.00 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
90; 9 | — |
| SECONDARY Number of Participants With Investigator-Identified Serious Infections |
3 | — |
| SECONDARY Number of Participants With Injection Site Reactions |
27 | — |
| SECONDARY Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities |
5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
55.9; 76.5; 82.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
16.1; 36.3; 57.8 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
3.2; 13.4; 26.7 | — |
| SECONDARY Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24 |
6.2; -1.5; -2.3; -2.8 | — |
| SECONDARY Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24 |
5.4; -1.5; -2.2; -2.5 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24 |
1.3; -0.3; -0.4; -0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
- Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.
Exclusion Criteria
- Prior treatment with etanercept.
- Presence of active infection or active or untreated tuberculosis.
Data sourced from ClinicalTrials.gov (NCT02378506) 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.