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BTT-1023 in Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Biotie Therapies Corp. Identifier:
First received: February 2, 2009
Last updated: February 2, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: BTT-1023 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Biotie Therapies Corp.:

Primary Outcome Measures:
  • Incidence and intensity of adverse events [ Time Frame: 17 wk ]

Secondary Outcome Measures:
  • Serum concentrations of the verum [ Time Frame: 17 wk ]
  • Disease activity [ Time Frame: 17 wk ]

Enrollment: 24
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTT1023 Drug: BTT-1023
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult-onset rheumatoid arthritis

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00851240

Sofia, Bulgaria
Sofia, Bulgaria, 1612
Sponsors and Collaborators
Biotie Therapies Corp.
Study Director: Antero Kallio, MD Biotie Therapies Corp.
  More Information

Responsible Party: Biotie Therapies Corp. Identifier: NCT00851240     History of Changes
Other Study ID Numbers: BTT12-CD015
Study First Received: February 2, 2009
Last Updated: February 2, 2012

Keywords provided by Biotie Therapies Corp.:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017