BTT-1023 in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotie Therapies Corp.
ClinicalTrials.gov Identifier:
NCT00851240
First received: February 2, 2009
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum concentrations of the verum [ Time Frame: 17 wk ] [ Designated as safety issue: No ]
  • Disease activity [ Time Frame: 17 wk ] [ Designated as safety issue: No ]

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
intravenous
Placebo Comparator: Placebo Drug: Placebo
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult-onset rheumatoid arthritis

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Biotie Therapies Corp.
ClinicalTrials.gov Identifier: NCT00851240     History of Changes
Other Study ID Numbers: BTT12-CD015
Study First Received: February 2, 2009
Last Updated: February 2, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency

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

ClinicalTrials.gov processed this record on April 23, 2014