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NCT01123655 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01123655: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT01123655 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01123655, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a Phase I clinical trial to determine whether orally administered APL A12 at one or more doses is superior to placebo in effecting a 25% reduction in interferon (IFN) stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In an effort to learn more about the mechanism of action of APL A12, the investigators will assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+ CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry combined with intracellular cytokine staining will be used in an effort to determine which T cell subset(s) is/are experiencing shifts in cytokine expression.
Primary Outcome
The primary outcome variable is the presence of a \> 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment.
Interventions
- DRUG Placebo
- DRUG APLA12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01123655 record still lists
NCT01123655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01123655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01123655 about?
NCT01123655 is a clinical study titled "Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients". This is a Phase I clinical trial to determine whether orally administered APL A12 at one or more doses is superior to placebo in effecting a 25% reduction in interferon (IFN) stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained from patients with Rheumatoid A...
What is the current status of trial NCT01123655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01123655?
The interventions under investigation include: Placebo (DRUG), APLA12 (DRUG).
Who is sponsoring clinical trial NCT01123655?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01123655's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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