Investigating Clinical Efficacy of Ofatumumab in Adult RA Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

This study is currently recruiting participants.

Verified by Genmab, January 2009

Sponsors and Collaborators:	Genmab GlaxoSmithKline
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00603525

Purpose

The purpose of this study is to determine the effect of ofatumumab combined with methotrexate in patients with rheumatoid arthritis who have responded inadequately to previous TNF-α inhibitor therapy

Condition	Intervention	Phase
Arthritis, Rheumatoid Rheumatoid Arthritis	Drug: Ofatumumab Drug: Placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Ofatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Adult Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to TNF-α Antagonist Therapy

Further study details as provided by Genmab:

Primary Outcome Measures:

To demonstrate efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy and safety of repeated courses of ofatumumab [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	236
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Drug: Ofatumumab I.V. infusion, 2 x 700mg
Placebo: Placebo Comparator	Drug: Placebo I.V. infusion 2 x placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inadequate response to previous or current TNF-α antagonist treatment after infliximab therapy, or adalimumab therapy, or etanercept therapy defined as:
Inadequate efficacy according to the investigator's judgment and/or
Intolerance defined as one or more side effects following at least one administration of one of the TNF-α antagonists listed above that reasonably results in the discontinuation of treatment with the TNF-α antagonist treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603525

Contacts

Contact: Lesley Kahl

+44 (0) 208 422 3434

Lesley.p.kahl@gsk.com

Show 49 Study Locations

Sponsors and Collaborators

Genmab

GlaxoSmithKline

Investigators

Principal Investigator:	Ronald van Vollenhoven, MD, PhD	Karolinska Institute
Study Director:	Hanne Storgaard Schultz, DVM	Genmab

More Information

Responsible Party:	Genmab A/S ( Hanne Storgaard Schultz, International Clincial Trial Manager )
Study ID Numbers:	GEN411/OFA110634, IND12060, EudraCT number:2007-002951-18
Study First Received:	January 16, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00603525
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009