A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715896
• Other study ID #: CD-IA-CAM-3001-1107
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2012
• Last updated: March 25, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Agence Francaise de Securite Sanitaire des Produits de Sante
• Study type: Interventional

Clinical Trial Summary

An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.

Description:

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the current study is to compare the efficacy and safety of a subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two anti-TNF agents with mavrilimumab

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A diagnosis of at least moderately-active adult onset RA

• At least 4 swollen joints

• Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol

• Receiving oral or injectable methotrexate, as defined by the protocol.

Exclusion Criteria:

• A rheumatic autoimmune disease or other inflammatory joint disease other than RA

• Previous treatment with biologic therapies other than anti-TNF for RA.

• Treatment with other DMARDs or NSAIDs, as defined by the protocol.

• Medical history as defined by the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Mavrilimumab or golimumab alternating with placebo subcutaneous injection
GM-CSR alpha inhibitor or TNF alpha Inhibitor alternating with placebo

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	San Miguel de Tucuman
Colombia	Research Site	Barranquilla
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Uherske Hradiste
Czech Republic	Research Site	Zlin
France	Research Site	Montpellier cedex 5
Greece	Research Site	Athens
Greece	Research Site	Heraklion
Greece	Research Site	Larissa
Hungary	Research Site	Baja
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Israel	Research Site	Kfar-Saba
Israel	Research Site	Petach-Tikva
Israel	Research Site	Rehovot
Mexico	Research Site	Merida
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Viseu
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Serbia	Research Site	Belgrade
Serbia	Research Site	Niska Banja
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice - Saca
Spain	Research Site	Barcelona
Spain	Research Site	Bilbao
Spain	Research Site	Malaga
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

Argentina,  Colombia,  Czech Republic,  France,  Greece,  Hungary,  Israel,  Mexico,  Portugal,  Russian Federation,  Serbia,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve American College of Rheumatology 20%/50%/70% improvement	Also included in the primary outcome measure are: disease activity score in 28 joints (DAS28) < 2.6, and Health Assessment Questionnaire Disability Index (HAQ-DI) improvement > 0.25	24 Weeks	No
Secondary	Incidence of Adverse Events	Number of participants with adverse events	Informed consent through to Week 24	Yes
Secondary	Maximum Serum Concentrations Following Mavrilimumab	Maximum serum concentrations (Cmax) following mavrilimumab administration	Day 1 to Week 24	No
Secondary	Incidence of Anti-drug Antibodies Against Mavrilimumab	Number of participants with anti-drug antibodies against mavrilimumab	Day 1 to Week 24	Yes
Secondary	DAS28-CRP	Change from baseline DAS28-CRP	Day 1 to Week 24	No
Secondary	Individual ACR components	Swollen and tender joint counts, patient assessment of pain, patient global assessment, physician global assessment, HAQ-DI, CRP and ESR	Day 1 to Week 24	No
Secondary	FACIT-fatigue	Change from baseline in FACIT-fatigue	Day 1 to Week 24	No
Secondary	ACRn	ACRn	Day 1 to week 24	No
Secondary	DAS28 EULAR response	Including treatment and number of anti-TNF failures	Every 2 weeks for 24weeks	No
Secondary	DAS28 Low Disease Activity		Every 2 weeks for 24 weeks	No
Secondary	Incidence of Serious Adverse Events	Number of participants with serious adverse events	Informed consent through to Week 24	Yes
Secondary	Incidence of Abnormal Laboratory Values	Number of participants with abnormal laboratory values	Informed consent through to Week 24	Yes
Secondary	Incidence of Abnormal Vital Sign Values	Number of participants with abnormal vital sign values	Informed consent through to Week 24	Yes
Secondary	Incidence of Abnormal Pulmonary Function Test Values	Number of participants with abnormal pulmonary function test values	Informed consent through to Week 24	Yes