BTT-1023 in Rheumatoid Arthritis

NCT ID: NCT00851240

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BTT1023

Group Type EXPERIMENTAL

BTT-1023

Intervention Type DRUG

intravenous

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous

Interventions

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BTT-1023

intravenous

Intervention Type DRUG

Placebo

Intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult-onset rheumatoid arthritis

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotie Therapies Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antero Kallio, MD

Role: STUDY_DIRECTOR

Biotie Therapies Corp.

Locations

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Sofia, Bulgaria

Sofia, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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BTT12-CD015

Identifier Type: -

Identifier Source: org_study_id

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