Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01185301 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)
A Phase 3 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
NCT01185301: Completed Phase 3 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01185301 is a Phase 3 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 395 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185301, a Phase 3 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).
Primary Outcome
Percentage of participants achieving low disease activity as defined by a clinical response (DAS28\[CRP\] \< 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates cl
Interventions
- DRUG methotrexate
- BIOLOGICAL adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01185301 record still lists
NCT01185301 is an interventional study that assigns participants to a tested intervention. The registered 395 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 (49% lower).
The record links to 0 conditions, and to 2 interventions - of which methotrexate is the first listed.
NCT01185301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185301 about?
NCT01185301 is a clinical study titled "Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)". The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).
What is the current status of trial NCT01185301?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2010-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01185301?
The interventions under investigation include: methotrexate (DRUG), adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01185301?
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 NCT01185301's enrollment target sits among peer trials
395 965th of 2000 higher than 1,034 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07207369 · 395 participants · Phase 3
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
- NCT05633615 · 396 participants · Phase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- NCT06227910 · 396 participants · Phase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- NCT06545331 · 396 participants · Phase 1
Study of XB010 in Subjects With Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia