CClinicalTrials.gg
CompletedNCT00851240Updated Feb 3, 2012

BTT-1023 in Rheumatoid Arthritis

A Phase 1 interventional study of BTT-1023 and Placebo in Rheumatoid Arthritis, sponsored by Biotie Therapies Corp.. Completed at 1 site in Bulgaria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Biotie Therapies Corp. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • rheumatoid arthritis
  • safety
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 24 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Biotie Therapies Corp. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult-onset rheumatoid arthritis

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    BTT1023

    Drug: BTT-1023

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBTT-1023

    intravenous

  • DrugPlacebo

    Intravenous

06

What researchers measure

Primary outcomes

  1. Incidence and intensity of adverse events

    Time frame: 17 wk

Secondary outcomes

  1. Serum concentrations of the verum

    Time frame: 17 wk

  2. Disease activity

    Time frame: 17 wk

07

Study locations

1 site
  • Sofia, Bulgaria
    Sofia, 1612, Bulgaria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00851240
Lead sponsor
Biotie Therapies Corp.
Responsible party
Sponsor
First posted
Feb 25, 2009
Start date
Feb 2009
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Feb 3, 2012

Study contacts

Antero Kallio, MD
study director · Biotie Therapies Corp.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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