NCT00291928 is a Phase 2 clinical trial of Part A in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00291928?

NCT00291928 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00291928?

Interventions in NCT00291928: Part A, Part B.

What condition does NCT00291928 study?

NCT00291928 studies Arthritis, Rheumatoid.

Is NCT00291928 still recruiting?

NCT00291928 is currently completed. Last updated 8 November 2012.

Last reviewed 2012-11-08 · How we verify

NCT00291928

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

A Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs

Completed Phase 2 Last updated 8 November 2012

What this trial tests

Phase 2 trial testing Part A in Arthritis, Rheumatoid in 201 participants. Completed in 1 September 2007.

Timeline

1 February 2005

Primary endpoint
1 September 2007

1 September 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	201
Start date	1 February 2005
Primary completion	1 September 2007
Estimated completion	1 September 2007

Drugs / interventions tested

Part A — full drug profile →
Part B — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, 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.

To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis
Time frame: 24 weeks
To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 12 to 24 weeks after initiation of treatment
Time frame: 24 weeks

Sponsor's own description

The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in patients with active RA. Furthermore, the trial is designed to identify the dose levels to be used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS responses).

Publications & conference data

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

Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment.
Du FH, Mills EA, Mao-Draayer Y. · · 2017 · cited 120× · PMID 29143151 · DOI 10.1007/s13317-017-0100-y
B-cell targeted therapeutics in clinical development.
Blüml S, McKeever K, Ettinger R, Smolen J, et al · · 2013 · cited 74× · PMID 23566679 · DOI 10.1186/ar3906
Ofatumumab.
Zhang B. · · 2009 · cited 55× · PMID 20068404 · DOI 10.4161/mabs.1.4.8895

Verify or expand the search:

Other trials of Part A

Trials testing the same drug.

NCT05082051 — Oral CDX-7108 in Healthy Adults and EPI Subjects · Phase 1 · completed
NCT04510649 — Surufatinib DDI With a PPI and a CYP3A Inducer · Phase 1 · completed
NCT03474640 — Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies · Phase 1 · completed

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 GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet 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 NCT00291928 (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 GlaxoSmithKline
Last refreshed: 8 November 2012

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/NCT00291928.

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