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

NCT00611455 | Terminated Phase 3 Results

• 2 other identifiers: 110635GEN410
• Study Type: interventional
• Target: 265
• Locations: 13 countries
• Sites: 45

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24

  The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced \>=20% improvement from baseline in TJC and SJC and a \>=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

  Baseline and Week 24

Secondary Outcomes (48)

• Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20

  Baseline and Weeks 4, 8, 12, 16, and 20

• Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Median ACRn at Weeks 4, 8, 12, 16, 20, and 24

  Weeks 4, 8, 12, 16, 20, and 24

• Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)

  Weeks 4, 8, 12, 16, 20, and 24

Study Arms (2)

ofatumumab

EXPERIMENTAL

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

Drug: ofatumumab

1000 ml Saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ofatumumab 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

ofatumumab

Placebo 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

1000 ml Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (45)

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN, Argentina

Location

GSK Investigational Site

Quilmes, Buenos Aires, 1878, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

Location

GSK Investigational Site

Córdoba, 5000, Argentina

Location

GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

Location

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

GSK Investigational Site

Maroochydore, Queensland, 4558, Australia

Location

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Malvern, Victoria, 3144, Australia

Location

GSK Investigational Site

Shenton Park, Western Australia, 6008, Australia

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Merksem, 2170, Belgium

Location

GSK Investigational Site

Viña del Mar, Región de Valparaíso, 2570017, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7501126, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 8380456, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Ostrava Trebovice, 722 00, Czechia

Location

GSK Investigational Site

Prague, 128 50, Czechia

Location

GSK Investigational Site

Zlín, 760 01, Czechia

Location

GSK Investigational Site

Budapest, 1023, Hungary

Location

GSK Investigational Site

Győr, 9024, Hungary

Location

GSK Investigational Site

Callao, Callao 2, Peru

Location

GSK Investigational Site

Lima, Lima 27, Peru

Location

GSK Investigational Site

Bialystok, 15-351, Poland

Location

GSK Investigational Site

Bialystok, 15337, Poland

Location

GSK Investigational Site

Bydgoszcz, 85168, Poland

Location

GSK Investigational Site

Warsaw, 02-256, Poland

Location

GSK Investigational Site

Wroclaw, 50-088, Poland

Location

GSK Investigational Site

Bucharest, 020047, Romania

Location

GSK Investigational Site

Moscow, 115522, Russia

Location

GSK Investigational Site

Saint Petersburg, 190068, Russia

Location

GSK Investigational Site

Saratov, 410012, Russia

Location

GSK Investigational Site

Yaroslavl, 150003, Russia

Location

GSK Investigational Site

Yekaterinburg, 620102, Russia

Location

GSK Investigational Site

Gauteng, 1459, South Africa

Location

GSK Investigational Site

Parow, 7505, South Africa

Location

GSK Investigational Site

Granada, 18012, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Santander, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

GSK Investigational Site

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

GSK Investigational Site

Cannock, WS11 5XY, United Kingdom

Location

GSK Investigational Site

Leytonstone, London, E11 1NR, United Kingdom

Location

GSK Investigational Site

Maidstone, ME16 9QQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21859685 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: February 11, 2008
• Study Start: January 1, 2008
• Primary Completion: June 8, 2009
• Study Completion: July 15, 2013
• Last Updated: November 6, 2017
• Results First Posted: October 28, 2011

Record last verified: 2017-11

Locations

PL (5); ZA (2); BE (2); AU (5); HU (2); CZ (3); CL (4); RU (5); ES (5); GB (4); AR (5); PE (2); RO (1)