Back to resultsSafety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALD518
Infusion without ALD518'
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Active Rheumatoid Arthritis for at least 16 weeks duration
- Have a C-reactive protein (CRP) of ≥ 10mg/L
- Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Exclusion Criteria:
- Arthritis onset prior to 16 years old
- Received any biologic therapy in the previous 12 months
- A history of or currently have active tuberculosis
- Any clinically significant concurrent medical condition
Sites / Locations
- K-W Musculoskeletal Research, Inc.
- Rheumatology Research Associates
- V. Tsitlanadze Scientific Practical Centre of Rheumatology
- Medulla Chemotherapy and Immunotherapy Clinic
- Chanre Rheumatology and Immunology Center and Research
- KLE Society Hospital and Medical Research Centre
- Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
- St. John's Medical College Hospital
- Krishna Institute of Medical Sciences Ltd.
- Miriada Center Private Clinic of Professor Sierakowski
- Nonpublic Centre of Medical Care Reumed
- NOVAMED - Medical Center of Poznan
- Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
- Szezecin Clinic of Rheumatology and Internal Diseases
- Regional Clinical Hospital of War Veterans
- Institute of Clinical and Experimental Lymphology
- Ryazan Regional Clinical Cardiologic Dispensary
- City Hospital #26
- Saint Petersburg Medical Academy of Postgraduate Study
- Saint-Petersburg State Medical Academy named after I. I. Mechnikov
- Regional War Veterans' Hospital
- Tomsk Regional Clinical Hospital
- Tula Regional Clinical Hospital
- Clinical Hospital of Emergency Care named after N.V. Solovyev
- Institute of Rheumatology
- Institute for Rehabilitation and Treatment Niska Banja
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
ALD518 80 mg
ALD518 160 mg
ALD518 320 mg
No ALD518
Outcomes
Primary Outcome Measures
Incidence and severity of AEs and SAEs during the study
Secondary Outcome Measures
To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00867516
Brief Title
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
Acronym
ALD518-003
Official Title
A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
Detailed Description
This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ALD518 80 mg
Arm Title
2
Arm Type
Experimental
Arm Description
ALD518 160 mg
Arm Title
3
Arm Type
Experimental
Arm Description
ALD518 320 mg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
No ALD518
Intervention Type
Biological
Intervention Name(s)
ALD518
Intervention Description
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
Intervention Type
Biological
Intervention Name(s)
Infusion without ALD518'
Intervention Description
250 cc Normal saline IV over one hour Weeks 1 and 8.
Primary Outcome Measure Information:
Title
Incidence and severity of AEs and SAEs during the study
Time Frame
During entire length of study
Secondary Outcome Measure Information:
Title
To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12
Time Frame
12 weeks after Dose 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active Rheumatoid Arthritis for at least 16 weeks duration
Have a C-reactive protein (CRP) of ≥ 10mg/L
Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Exclusion Criteria:
Arthritis onset prior to 16 years old
Received any biologic therapy in the previous 12 months
A history of or currently have active tuberculosis
Any clinically significant concurrent medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Smith, MD, FRCP
Organizational Affiliation
Alder BioPharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
K-W Musculoskeletal Research, Inc.
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
Rheumatology Research Associates
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH IA2
Country
Canada
Facility Name
V. Tsitlanadze Scientific Practical Centre of Rheumatology
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Medulla Chemotherapy and Immunotherapy Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Chanre Rheumatology and Immunology Center and Research
City
Malleshwaram
State/Province
Bangalore
ZIP/Postal Code
560 003
Country
India
Facility Name
KLE Society Hospital and Medical Research Centre
City
Nehru Nagar
State/Province
Belgaum
ZIP/Postal Code
590 010
Country
India
Facility Name
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
City
Ramadaspeth
State/Province
Nagpur
ZIP/Postal Code
440 010
Country
India
Facility Name
St. John's Medical College Hospital
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Krishna Institute of Medical Sciences Ltd.
City
Secunderabad
ZIP/Postal Code
500 003
Country
India
Facility Name
Miriada Center Private Clinic of Professor Sierakowski
City
Bialystok
ZIP/Postal Code
15-297
Country
Poland
Facility Name
Nonpublic Centre of Medical Care Reumed
City
Lublin
ZIP/Postal Code
26-607
Country
Poland
Facility Name
NOVAMED - Medical Center of Poznan
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
Facility Name
Szezecin Clinic of Rheumatology and Internal Diseases
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Regional Clinical Hospital of War Veterans
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Institute of Clinical and Experimental Lymphology
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Cardiologic Dispensary
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
City Hospital #26
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Saint Petersburg Medical Academy of Postgraduate Study
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Saint-Petersburg State Medical Academy named after I. I. Mechnikov
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Regional War Veterans' Hospital
City
Saratov
ZIP/Postal Code
410002
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Tula Regional Clinical Hospital
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Clinical Hospital of Emergency Care named after N.V. Solovyev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rehabilitation and Treatment Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
12. IPD Sharing Statement
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Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
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