Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Biological: ALD518; Biological: Infusion without ALD518'

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).

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2M 5N6
      • K-W Musculoskeletal Research, Inc.
    • Ottawa, Ontario, Canada, KIH IA2
      • Rheumatology Research Associates
• Georgia
  • Tbilisi, Georgia, 0186
    • Medulla Chemotherapy and Immunotherapy Clinic
  • Tbilisi, Georgia, 0102
    • V. Tsitlanadze Scientific Practical Centre of Rheumatology
• India
  • Bangalore, India, 560 034
    • St. John's Medical College Hospital
  • Secunderabad, India, 500 003
    • Krishna Institute of Medical Sciences Ltd.
  • Bangalore
    • Malleshwaram, Bangalore, India, 560 003
      • ChanRe Rheumatology And Immunology Center And Research
  • Belgaum
    • Nehru Nagar, Belgaum, India, 590 010
      • KLE Society Hospital and Medical Research Centre
  • Nagpur
    • Ramadaspeth, Nagpur, India, 440 010
      • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
• Poland
  • Bialystok, Poland, 15-297
    • Miriada Center Private Clinic of Professor Sierakowski
  • Lublin, Poland, 26-607
    • Nonpublic Centre of Medical Care Reumed
  • Poznan, Poland, 60-773
    • NOVAMED - Medical Center of Poznan
  • Sopot, Poland, 81-759
    • Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
  • Szczecin, Poland, 71-252
    • Szezecin Clinic of Rheumatology and Internal Diseases
• Russian Federation
  • Kemerovo, Russian Federation, 650099
    • Regional Clinical Hospital of War Veterans
  • Novosibirsk, Russian Federation, 630117
    • Institute of Clinical and Experimental Lymphology
  • Ryazan, Russian Federation, 390026
    • Ryazan Regional Clinical Cardiologic Dispensary
  • Saint Petersburg, Russian Federation, 196247
    • City Hospital #26
  • Saint-Petersburg, Russian Federation, 191015
    • Saint Petersburg Medical Academy of Postgraduate Study
  • Saint-Petersburg, Russian Federation, 195067
    • Saint-Petersburg State Medical Academy named after I. I. Mechnikov
  • Saratov, Russian Federation, 410002
    • Regional War Veterans' Hospital
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
  • Tula, Russian Federation, 300053
    • Tula Regional Clinical Hospital
  • Yaroslavl, Russian Federation, 150003
    • Clinical Hospital of Emergency Care named after N.V. Solovyev
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Niska Banja, Serbia, 18205
    • Institute for Rehabilitation and Treatment Niska Banja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of AEs and SAEs during the study	During entire length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 weeks after Dose 1

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Jeffrey Smith, MD, FRCP, Alder Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (ESTIMATE): March 23, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ALD518-CLIN-003