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BTT-1023 in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00851240
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Biotie Therapies Corp.

Study Description
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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

Study Design
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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

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: BTT1023 Drug: BTT-1023
intravenous
Placebo Comparator: Placebo Drug: Placebo
Intravenous


Outcome Measures
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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 ]

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

Inclusion Criteria:

  • adult-onset rheumatoid arthritis

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00851240


Locations
Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria, 1612
Sponsors and Collaborators
Biotie Therapies Corp.
Investigators
Study Director: Antero Kallio, MD Biotie Therapies Corp.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Biotie Therapies Corp.
ClinicalTrials.gov Identifier: NCT00851240     History of Changes
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
safety

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases