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NCT00085644 · ClinicalTrials.gov registry record · Phase 3
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
NCT00085644: Completed Phase 3 study, sponsored by Abbott.
NCT00085644 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 315 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085644, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).
Primary Outcome
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\]-100 \[severe\]), Total Back Pain VAS (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy\]-100\[impossible\]); and Inflammation VAS (0 \[none\]-10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL adalimumab (D2E7)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00085644 record still lists
NCT00085644 is an interventional study that assigns participants to a tested intervention. The registered 315 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 (59% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00085644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085644 about?
NCT00085644 is a clinical study titled "Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis". The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NS...
What is the current status of trial NCT00085644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2004-01. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00085644?
The interventions under investigation include: placebo (BIOLOGICAL), adalimumab (D2E7) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00085644?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00085644's enrollment target sits among peer trials
315 1092nd of 2000 higher than 905 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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