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

Arm | Intervention/treatment |
---|---|
Experimental: BTT1023 |
Drug: BTT-1023
intravenous
|
Placebo Comparator: Placebo |
Drug: Placebo
Intravenous
|
- Incidence and intensity of adverse events [ Time Frame: 17 wk ]
- Serum concentrations of the verum [ Time Frame: 17 wk ]
- Disease activity [ Time Frame: 17 wk ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult-onset rheumatoid arthritis
Exclusion Criteria:

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
Bulgaria | |
Sofia, Bulgaria | |
Sofia, Bulgaria, 1612 |
Study Director: | Antero Kallio, MD | Biotie Therapies Corp. |
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 |