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NCT00195702 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 619
- Enrollment target
NCT00195702: Completed Phase 3 study, sponsored by Abbott.
NCT00195702 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 619 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195702, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 619 participants
- Enrollment target
Study Summary
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.
Primary Outcome
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving a
Interventions
- DRUG Placebo
- BIOLOGICAL Adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 619 participants |
| Start Date | 2000-02 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
What the finished NCT00195702 record still lists
NCT00195702 is an interventional study that assigns participants to a tested intervention. The registered 619 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 (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00195702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195702 about?
NCT00195702 is a clinical study titled "Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.". The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension ph...
What is the current status of trial NCT00195702?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 619 participants. The study started on 2000-02. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00195702?
The interventions under investigation include: Placebo (DRUG), Adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00195702?
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 NCT00195702's enrollment target sits among peer trials
619 591st of 2000 higher than 1,410 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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