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

CSL Behring logo

CSL Behring

Status and phase

Completed
Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Biological: Infusion without ALD518'
Biological: ALD518

Study type

Interventional

Funder types

Industry

Identifiers

NCT00867516
ALD518-CLIN-003

Details and patient eligibility

About

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.

Full 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).

Enrollment

127 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

127 participants in 4 patient groups, including a placebo group

1
Experimental group
Description:
ALD518 80 mg
Treatment:
Biological: ALD518
2
Experimental group
Description:
ALD518 160 mg
Treatment:
Biological: ALD518
3
Experimental group
Description:
ALD518 320 mg
Treatment:
Biological: ALD518
4
Placebo Comparator group
Description:
No ALD518
Treatment:
Biological: Infusion without ALD518'

Trial contacts and locations

26

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems