BTT-1023 in Rheumatoid Arthritis - Full Text View

Sponsor:	Biotie Therapies Corp.
Information provided by (Responsible Party):	Biotie Therapies Corp.
ClinicalTrials.gov Identifier:	NCT00851240

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 I

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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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 February 09, 2012