BTT-1023 in Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: BTT-1023; Drug: Placebo

• Registration Number: NCT00851240
• Lead Sponsor: Biotie Therapies Corp.

Brief Summary

Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• adult-onset rheumatoid arthritis

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTT1023	BTT-1023	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence and intensity of adverse events	17 wk

Secondary Outcome Measures

Name	Time	Method
Disease activity	17 wk
Serum concentrations of the verum	17 wk

Trial Locations

Locations (1)

Sofia, Bulgaria; 🇧🇬 Sofia, Bulgaria