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NCT01970475 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 526
- Enrollment target
NCT01970475: Completed Phase 3 study, sponsored by Amgen.
NCT01970475 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 526 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970475, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 526 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).
Primary Outcome
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured
Interventions
- BIOLOGICAL Adalimumab
- BIOLOGICAL ABP 501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01970475 record still lists
NCT01970475 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Adalimumab is the first listed.
NCT01970475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970475 about?
NCT01970475 is a clinical study titled "Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis". The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).
What is the current status of trial NCT01970475?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 526 participants. The study started on 2013-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01970475?
The interventions under investigation include: Adalimumab (BIOLOGICAL), ABP 501 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01970475?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01970475's enrollment target sits among peer trials
526 715th of 2000 higher than 1,286 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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