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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.
 
ClinicalTrials.gov Identifier: NCT00867516
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Vitaeris INC

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Biological: ALD518 Biological: Infusion without ALD518` Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence and severity of AEs and SAEs during the study [ Time Frame: During entire length of study ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867516


Locations
Show Show 26 study locations
Sponsors and Collaborators
Vitaeris INC
Investigators
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Study Director: Jeffrey Smith, MD, FRCP Alder BioPharmaceuticals

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Responsible Party: Vitaeris INC
ClinicalTrials.gov Identifier: NCT00867516    
Other Study ID Numbers: ALD518-CLIN-003
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases