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BTT-1023 in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Bulgaria

Study Type

Interventional

Intervention

BTT-1023

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult-onset rheumatoid arthritis

Exclusion Criteria:

Sites / Locations

Sofia, Bulgaria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTT1023

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence and intensity of adverse events

Secondary Outcome Measures

Serum concentrations of the verum

Disease activity

Full Information

NCT ID

NCT00851240

First Posted

February 2, 2009

Last Updated

February 2, 2012

Sponsor

Biotie Therapies Corp.

1. Study Identification

Unique Protocol Identification Number

NCT00851240

Brief Title

BTT-1023 in Rheumatoid Arthritis

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotie Therapies Corp.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BTT1023

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BTT-1023

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous

Primary Outcome Measure Information:

Title

Incidence and intensity of adverse events

Time Frame

17 wk

Secondary Outcome Measure Information:

Title

Serum concentrations of the verum

Time Frame

17 wk

Title

Disease activity

Time Frame

17 wk

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult-onset rheumatoid arthritis Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antero Kallio, MD

Organizational Affiliation

Biotie Therapies Corp.

Official's Role

Study Director

Facility Information:

Facility Name

Sofia, Bulgaria

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

12. IPD Sharing Statement

Learn more about this trial

BTT-1023 in Rheumatoid Arthritis

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