NCT00851240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

February 2, 2009

Last Update Submit

February 2, 2012

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritissafety

Outcome Measures

Primary Outcomes (1)

  • Incidence and intensity of adverse events

    17 wk

Secondary Outcomes (2)

  • Serum concentrations of the verum

    17 wk

  • Disease activity

    17 wk

Study Arms (2)

BTT1023

EXPERIMENTAL
Drug: BTT-1023

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BTT-1023DRUG

intravenous

BTT1023
PlaceboDRUG

Intravenous

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult-onset rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofia, Bulgaria

Sofia, 1612, Bulgaria

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

timolumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Antero Kallio, MD

    Biotie Therapies Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 25, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

BU(1)