Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
NCT ID: NCT00867516
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups:
Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo
In all treatment groups patients will continue to take a stable dose of methotrexate.
There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ALD518 80 mg
ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
2
ALD518 160 mg
ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
3
ALD518 320 mg
ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
4
No ALD518
Infusion without ALD518'
250 cc Normal saline IV over one hour Weeks 1 and 8.
Interventions
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ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
Infusion without ALD518'
250 cc Normal saline IV over one hour Weeks 1 and 8.
Eligibility Criteria
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Inclusion Criteria
* Have a C-reactive protein (CRP) of ≥ 10mg/L
* Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Exclusion Criteria
* Received any biologic therapy in the previous 12 months
* A history of or currently have active tuberculosis
* Any clinically significant concurrent medical condition
18 Years
80 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Smith, MD, FRCP
Role: STUDY_DIRECTOR
Alder BioPharmaceuticals
Locations
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K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, Canada
Rheumatology Research Associates
Ottawa, Ontario, Canada
V. Tsitlanadze Scientific Practical Centre of Rheumatology
Tbilisi, , Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
Chanre Rheumatology and Immunology Center and Research
Malleshwaram, Bangalore, India
KLE Society Hospital and Medical Research Centre
Nehru Nagar, Belgaum, India
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Ramadaspeth, Nagpur, India
St. John's Medical College Hospital
Bangalore, , India
Krishna Institute of Medical Sciences Ltd.
Secunderabad, , India
Miriada Center Private Clinic of Professor Sierakowski
Bialystok, , Poland
Nonpublic Centre of Medical Care Reumed
Lublin, , Poland
NOVAMED - Medical Center of Poznan
Poznan, , Poland
Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
Sopot, , Poland
Szezecin Clinic of Rheumatology and Internal Diseases
Szczecin, , Poland
Regional Clinical Hospital of War Veterans
Kemerovo, , Russia
Institute of Clinical and Experimental Lymphology
Novosibirsk, , Russia
Ryazan Regional Clinical Cardiologic Dispensary
Ryazan, , Russia
Saint Petersburg Medical Academy of Postgraduate Study
Saint Petersburg, , Russia
Saint-Petersburg State Medical Academy named after I. I. Mechnikov
Saint Petersburg, , Russia
City Hospital #26
Saint Petersburg, , Russia
Regional War Veterans' Hospital
Saratov, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Tula Regional Clinical Hospital
Tula, , Russia
Clinical Hospital of Emergency Care named after N.V. Solovyev
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Institute for Rehabilitation and Treatment Niska Banja
Niška Banja, , Serbia
Countries
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Other Identifiers
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ALD518-CLIN-003
Identifier Type: -
Identifier Source: org_study_id
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