NCT00867516 (ALD518-003) is a Phase 2 clinical trial of ALD518 in Arthritis, Rheumatoid, sponsored by CSL Behring.

Who is sponsoring NCT00867516?

NCT00867516 is sponsored by CSL Behring.

What drugs are being tested in NCT00867516?

Interventions in NCT00867516: ALD518, Infusion without ALD518'.

What condition does NCT00867516 study?

NCT00867516 studies Arthritis, Rheumatoid.

Is NCT00867516 still recruiting?

NCT00867516 is currently completed. Last updated 7 July 2020.

Last reviewed 2020-07-07 · How we verify

NCT00867516: ALD518-003

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 7 July 2020

What this trial tests

Phase 2 trial testing ALD518 in Arthritis, Rheumatoid in 127 participants. Completed in 1 December 2009.

Timeline

1 October 2008

Primary endpoint
1 June 2009

1 December 2009

Quick facts

Lead sponsor	CSL Behring
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	127
Start date	1 October 2008
Primary completion	1 June 2009
Estimated completion	1 December 2009
Sites	26 locations across Canada, Georgia, India, Poland, Russia, Serbia

Drugs / interventions tested

ALD518 — full drug profile →
Infusion without ALD518' — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

CSL Behring — full company profile →

Who can join

Adults 18 to 80, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence and severity of AEs and SAEs during the study
Time frame: During entire length of study

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The role of inflammation in autoimmune disease: a therapeutic target.
Xiang Y, Zhang M, Jiang D, Su Q, et al · · 2023 · cited 104× · PMID 37859999 · DOI 10.3389/fimmu.2023.1267091
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497

Verify or expand the search:

Other recruiting trials for Arthritis, Rheumatoid

Currently open trials in the same condition.

NCT07176390 — A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) · Phase 2 · recruiting
NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study · Phase 4 · recruiting
NCT06492200 — Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis · NA · recruiting
NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants · recruiting

Other CSL Behring trials

Trials by the same sponsor.

NCT07326592 — Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza · Phase 4 · not yet recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00867516 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CSL Behring
Last refreshed: 7 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00867516.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing