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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00867516
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
Vitaeris INC

Tracking Information
First Submitted Date  ICMJE March 20, 2009
First Posted Date  ICMJE March 23, 2009
Last Update Posted Date September 15, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2009)
Incidence and severity of AEs and SAEs during the study [ Time Frame: During entire length of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Biological: ALD518
    Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
  • Biological: Infusion without ALD518`
    250 cc Normal saline IV over one hour Weeks 1 and 8.
Study Arms  ICMJE
  • Experimental: 1
    ALD518 80 mg
    Intervention: Biological: ALD518
  • Experimental: 2
    ALD518 160 mg
    Intervention: Biological: ALD518
  • Experimental: 3
    ALD518 320 mg
    Intervention: Biological: ALD518
  • Placebo Comparator: 4
    No ALD518
    Intervention: Biological: Infusion without ALD518`
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2009)
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Georgia,   India,   Poland,   Russian Federation,   Serbia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00867516
Other Study ID Numbers  ICMJE ALD518-CLIN-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vitaeris INC
Study Sponsor  ICMJE Vitaeris INC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeffrey Smith, MD, FRCP Alder BioPharmaceuticals
PRS Account Vitaeris INC
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP