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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

NCT01751776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-03-21

Study results available
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Summary

To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI 655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after 12 weeks of treatment

Conditions

  • Arthritis, Rheumatoid
  • Healthy

Interventions

DRUG

Placebo matching BI 655064

Placebo matching BI 655064 injected subcutaneous.

DRUG

BI 655064

BI 655064 injected subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-18
Primary Completion
2015-03-02
Completion
2015-04-27

Countries

  • Czechia
  • Germany
  • Netherlands
  • New Zealand
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751776 on ClinicalTrials.gov