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Completed

NCT Number: NCT00851240

BTT-1023 in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sofia, Bulgaria

Sofia, 1612, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult-onset rheumatoid arthritis

Exclusion criteria

-

Treatment and study plan

BTT-1023

Drug

intravenous

Placebo

Drug

Intravenous

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

Sponsors and collaborators

Lead sponsor

Biotie Therapies Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2009
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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