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BTT-1023 in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851240
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Biotie Therapies Corp.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BTT-1023 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BTT1023 Drug: BTT-1023

Placebo Comparator: Placebo Drug: Placebo

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • adult-onset rheumatoid arthritis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851240

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

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Responsible Party: Biotie Therapies Corp. Identifier: NCT00851240    
Other Study ID Numbers: BTT12-CD015
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012
Keywords provided by Biotie Therapies Corp.:
rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs