BTT-1023 in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851240
• Other study ID #: BTT12-CD015
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2009
• Last updated: February 2, 2012
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2012
• Source: Biotie Therapies Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult-onset rheumatoid arthritis

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BTT-1023
intravenous
• Placebo
Intravenous

Locations

Country	Name	City	State
Bulgaria	Sofia, Bulgaria	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Biotie Therapies Corp.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and intensity of adverse events		17 wk	Yes
Secondary	Serum concentrations of the verum		17 wk	No
Secondary	Disease activity		17 wk	No