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NCT01185288 · ClinicalTrials.gov registry record · Phase 4
A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)
A Phase 4 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 4
- Development phase
- 309
- Enrollment target
NCT01185288: Completed Phase 4 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01185288 is a Phase 4 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 309 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185288, a Phase 4 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 309 participants
- Enrollment target
Study Summary
This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).
Primary Outcome
The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score \< 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.
Interventions
- BIOLOGICAL Adalimumab
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01185288 record still lists
NCT01185288 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Adalimumab is the first listed.
NCT01185288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185288 about?
NCT01185288 is a clinical study titled "A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)". This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in co...
What is the current status of trial NCT01185288?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 309 participants. The study started on 2010-09. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01185288?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01185288?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01185288's enrollment target sits among peer trials
309 263rd of 2000 higher than 1,738 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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