Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Alder Biopharmaceuticals, Inc.
Information provided by:	Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00867516

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Placebo Comparator 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
Rheumatology Research Associates
Ottawa, Ontario, Canada, KIH IA2
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, Canada, N2M 5N6
Georgia
V. Tsitlanadze Scientific Practical Centre of Rheumatology
Tbilisi, Georgia, 0102
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia, 0186
India
Krishna Institute of Medical Sciences Ltd.
Secunderabad, India, 500 003
St. John's Medical College Hospital
Bangalore, India, 560 034
India, Bangalore
Chanre Rheumatology and Immunology Center and Research
Malleshwaram, Bangalore, India, 560 003
India, Belgaum
KLE Society Hospital and Medical Research Centre
Nehru Nagar, Belgaum, India, 590 010
India, Nagpur
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Ramadaspeth, Nagpur, India, 440 010
Poland
Szezecin Clinic of Rheumatology and Internal Diseases
Szczecin, Poland, 71-252
Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
Sopot, Poland, 81-759
Nonpublic Centre of Medical Care Reumed
Lublin, Poland, 26-607
NOVAMED - Medical Center of Poznan
Poznan, Poland, 60-773
Miriada Center Private Clinic of Professor Sierakowski
Bialystok, Poland, 15-297
Russian Federation
Regional Clinical Hospital of War Veterans
Kemerovo, Russian Federation, 650099
Institute of Clinical and Experimental Lymphology
Novosibirsk, Russian Federation, 630117
Tomsk Regional Clinical Hospital
Tomsk, Russian Federation, 634063
Ryazan Regional Clinical Cardiologic Dispensary
Ryazan, Russian Federation, 390026
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
City Hospital #26
Saint Petersburg, Russian Federation, 196247
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 of Rheumatology
Belgrade, Serbia, 11000
Institute for Rehabilitation and Treatment Niska Banja
Niska Banja, Serbia, 18205
Institute of Rheumatology
Belgrade, Serbia, 11000

Sponsors and Collaborators

Alder Biopharmaceuticals, Inc.

Investigators

Study Director:

Jeffrey Smith, MD, FRCP

Alder BioPharmaceuticals

More Information

No publications provided

Responsible Party:	Alder Biopharmaceuticals, Inc ( Jeffrey T L Smith, MD FRCP )
Study ID Numbers:	ALD518-CLIN-003
Study First Received:	March 20, 2009
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00867516 History of Changes
Health Authority:	Canada: Health Canada; Georgia: Ministry of Health; Russia: Ministry of Health and Social Development 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

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 25, 2009