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NCT02636907 · ClinicalTrials.gov registry record · Phase 2

Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
77
Enrollment target

NCT02636907: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT02636907 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02636907, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
77 participants
Enrollment target

Study Summary

This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.

Primary Outcome

The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when

Interventions

  • DRUG BI 695501 Autoinjector
  • DRUG BI 695501 Prefilled syringe

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2016-01-06
Est. Completion 2017-06-29
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT02636907 record still lists

NCT02636907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which BI 695501 Autoinjector is the first listed.

NCT02636907 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02636907 about?

NCT02636907 is a clinical study titled "Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe". This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.

What is the current status of trial NCT02636907?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2016-01-06. Estimated completion is 2017-06-29.

What interventions are being tested in trial NCT02636907?

The interventions under investigation include: BI 695501 Autoinjector (DRUG), BI 695501 Prefilled syringe (DRUG).

Who is sponsoring clinical trial NCT02636907?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02636907's enrollment target sits among peer trials

77 891st of 2000 higher than 1,108 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

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Source: ClinicalTrials.gov NCT02636907, the US trial registry maintained by the National Library of Medicine. NCT02636907 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.