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

History of Changes

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:

Genetics Home Reference related topics: rheumatoid arthritis

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

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 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 Autoimmune Diseases Connective Tissue Diseases	Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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