MedDataX Logo

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

NCT ID: NCT00611455

Last Updated: 2017-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2013-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study consists of a Double-blind , placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive ofatumumab (700mg x 2 infusions) or placebo ( saline x 2 infusions) in addition to their background methotrexate treatment. Patients who completed the 24 week Double-Blind period without receiving rescue DMARD treatment will be eligible to proceed into the 120 week Open-Label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity . Patients who have completed the Open-Label Period or have withdrawn will enter a maximum 2 year Follow-up Period, or until their Bcells return to normal or to baseline levels, whichever occurs earlier.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis, Rheumatoid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ofatumumab

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period

Group Type EXPERIMENTAL

ofatumumab

Intervention Type DRUG

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period

1000 ml Saline

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ofatumumab

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period

Intervention Type DRUG

Placebo

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years;
* Active disease at the time of screening as defined by:

≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);
* Inadequate response to previous or current methotrexate treatment;
* Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion Criteria

* Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA;
* Previous exposure to biologic anti-rheumatic therapies, including investigational compounds;
* Previous exposure to biologic DMARDs; Chronic or ongoing active infectious disease requiring systemic treatment;
* Clinically significant cardiac disease; History of significant cerebrovascular disease;
* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease;
* Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR;
* Serum IgG \< lower limit of normal;
* Breast feeding women or women with a positive pregnancy test at screening;
* Current participation in any other interventional clinical study;
* Patients known or suspected of not being able to comply with a study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Quilmes, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

GSK Investigational Site

Córdoba, , Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

GSK Investigational Site

Camperdown, New South Wales, Australia

Site Status

GSK Investigational Site

Maroochydore, Queensland, Australia

Site Status

GSK Investigational Site

Clayton, Victoria, Australia

Site Status

GSK Investigational Site

Malvern, Victoria, Australia

Site Status

GSK Investigational Site

Shenton Park, Western Australia, Australia

Site Status

GSK Investigational Site

Liège, , Belgium

Site Status

GSK Investigational Site

Merksem, , Belgium

Site Status

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Ostrava Trebovice, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Zlín, , Czechia

Site Status

GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Győr, , Hungary

Site Status

GSK Investigational Site

Callao, , Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saratov, , Russia

Site Status

GSK Investigational Site

Yaroslavl, , Russia

Site Status

GSK Investigational Site

Yekaterinburg, , Russia

Site Status

GSK Investigational Site

Gauteng, , South Africa

Site Status

GSK Investigational Site

Parow, , South Africa

Site Status

GSK Investigational Site

Granada, , Spain

Site Status

GSK Investigational Site

Málaga, , Spain

Site Status

GSK Investigational Site

Santander, , Spain

Site Status

GSK Investigational Site

Santander, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Wigan, Lancashire, United Kingdom

Site Status

GSK Investigational Site

Cannock, , United Kingdom

Site Status

GSK Investigational Site

Leytonstone, London, , United Kingdom

Site Status

GSK Investigational Site

Maidstone, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina Australia Belgium Chile Czechia Hungary Peru Poland Romania Russia South Africa Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Taylor PC, Quattrocchi E, Mallett S, Kurrasch R, Petersen J, Chang DJ. Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis. 2011 Dec;70(12):2119-25. doi: 10.1136/ard.2011.151522. Epub 2011 Aug 22.

Reference Type BACKGROUND
PMID: 21859685 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GEN410

Identifier Type: OTHER

Identifier Source: secondary_id

110635

Identifier Type: -

Identifier Source: org_study_id