Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00928512 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
237
Enrollment target

NCT00928512: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT00928512 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00928512, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
237 participants
Enrollment target

Study Summary

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

Primary Outcome

A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute

Interventions

  • DRUG Placebo
  • DRUG Secukinmab

Trial Details

FieldValue
Enrollment Target 237 participants
Start Date 2009-07
Est. Completion 2011-03
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00928512 record still lists

NCT00928512 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00928512 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00928512 about?

NCT00928512 is a clinical study titled "Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)". This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with M...

What is the current status of trial NCT00928512?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2009-07. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00928512?

The interventions under investigation include: Placebo (DRUG), Secukinmab (DRUG).

Who is sponsoring clinical trial NCT00928512?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00928512's enrollment target sits among peer trials

237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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

  • NCT05974176 · 237 participants · NA

    Considering Racial and Acculturation Stress in Addressing Trauma

  • NCT05012072 · 238 participants · NA

    Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

  • NCT05400252 · 238 participants · NA

    Whole Health in VA Mental Health: Omnis Salutis

  • NCT06380517 · 238 participants · Phase 3

    Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

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

Source: ClinicalTrials.gov NCT00928512, the US trial registry maintained by the National Library of Medicine. NCT00928512 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.