Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)
This study has been completed.
Sponsor:
Alder Biopharmaceuticals, Inc.
Information provided by:
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00867516
First received: March 20, 2009
Last updated: September 10, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Biological: ALD518 Biological: Infusion without ALD518` |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Alder Biopharmaceuticals, Inc.:
Primary Outcome Measures:
- Incidence and severity of AEs and SAEs during the study [ Time Frame: During entire length of study ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 weeks after Dose 1 ] [ Designated as safety issue: No ]
| Enrollment: | 127 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ALD518 80 mg
|
Biological: ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
|
|
Experimental: 2
ALD518 160 mg
|
Biological: ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
|
|
Experimental: 3
ALD518 320 mg
|
Biological: ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
|
|
Placebo Comparator: 4
No ALD518
|
Biological: Infusion without ALD518`
250 cc Normal saline IV over one hour Weeks 1 and 8.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867516
Locations
| Canada, Ontario | |
| K-W Musculoskeletal Research, Inc. | |
| Kitchener, Ontario, Canada, N2M 5N6 | |
| Rheumatology Research Associates | |
| Ottawa, Ontario, Canada, KIH IA2 | |
| Georgia | |
| V. Tsitlanadze Scientific Practical Centre of Rheumatology | |
| Tbilisi, Georgia, 0102 | |
| Medulla Chemotherapy and Immunotherapy Clinic | |
| Tbilisi, Georgia, 0186 | |
| India | |
| Chanre Rheumatology and Immunology Center and Research | |
| Malleshwaram, Bangalore, India, 560 003 | |
| KLE Society Hospital and Medical Research Centre | |
| Nehru Nagar, Belgaum, India, 590 010 | |
| Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics | |
| Ramadaspeth, Nagpur, India, 440 010 | |
| St. John's Medical College Hospital | |
| Bangalore, India, 560 034 | |
| Krishna Institute of Medical Sciences Ltd. | |
| Secunderabad, India, 500 003 | |
| Poland | |
| Miriada Center Private Clinic of Professor Sierakowski | |
| Bialystok, Poland, 15-297 | |
| Nonpublic Centre of Medical Care Reumed | |
| Lublin, Poland, 26-607 | |
| NOVAMED - Medical Center of Poznan | |
| Poznan, Poland, 60-773 | |
| Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko | |
| Sopot, Poland, 81-759 | |
| Szezecin Clinic of Rheumatology and Internal Diseases | |
| Szczecin, Poland, 71-252 | |
| Russian Federation | |
| Regional Clinical Hospital of War Veterans | |
| Kemerovo, Russian Federation, 650099 | |
| Institute of Clinical and Experimental Lymphology | |
| Novosibirsk, Russian Federation, 630117 | |
| Ryazan Regional Clinical Cardiologic Dispensary | |
| Ryazan, Russian Federation, 390026 | |
| City Hospital #26 | |
| Saint Petersburg, Russian Federation, 196247 | |
| Saint-Petersburg State Medical Academy named after I. I. Mechnikov | |
| Saint-Petersburg, Russian Federation, 195067 | |
| Saint Petersburg Medical Academy of Postgraduate Study | |
| Saint-Petersburg, Russian Federation, 191015 | |
| Regional War Veterans' Hospital | |
| Saratov, Russian Federation, 410002 | |
| Tomsk Regional Clinical Hospital | |
| Tomsk, Russian Federation, 634063 | |
| Tula Regional Clinical Hospital | |
| Tula, Russian Federation, 300053 | |
| Clinical Hospital of Emergency Care named after N.V. Solovyev | |
| Yaroslavl, Russian Federation, 150003 | |
| Serbia | |
| Institute of Rheumatology | |
| Belgrade, Serbia, 11000 | |
| Institute for Rehabilitation and Treatment Niska Banja | |
| Niska Banja, Serbia, 18205 | |
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
| Study Director: | Jeffrey Smith, MD, FRCP | Alder BioPharmaceuticals |
More Information
No publications provided
| Responsible Party: | Jeffrey T L Smith, MD FRCP, Alder Biopharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00867516 History of Changes |
| Other Study ID Numbers: | ALD518-CLIN-003 |
| Study First Received: | March 20, 2009 |
| Last Updated: | September 10, 2010 |
| Health Authority: | Canada: Health Canada Georgia: Ministry of Health Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products India: Drugs Controller General of India |
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 May 16, 2013