A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706926
• Other study ID #: CD-IA-CAM-3001-1071
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2012
• Last updated: August 15, 2014
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if mavrilimumab can provide benefit to subjects with rheumatoid arthritis.

Description:

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still 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 study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (ie, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A diagnosis of adult onset RA in line with the protocol

• Moderately active disease in line with the protocol

• A pre-defined number of swollen joints in line with the protocol

• Inadequate response to one or more conventional DMARDs

• No evidence of respiratory disease

Exclusion Criteria:

• A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA

• A history of, or current, inflammatory joint disease other than RA

• Previous treatment with the investigational drug

• Discontinuation of a biologic DMARD due to lack of efficacy.

• Non-compliant concurrent medications

• Non-compliance with medical history criteria

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

Drug:
• Mavrilimumab or placebo subcutaneous Injection
GM-CSFR alpha inhibitor

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma de Buenos Aire
Argentina	Research Site	Rosario
Argentina	Research Site	San Miguel de Tucuman
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Chile	Research Site	Santiago
Chile	Research Site	Vina del Mar
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Czech Republic	Research Site	Bruntal
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Ostrava - Trebovice
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 4 - Krc
Czech Republic	Research Site	Zlin
Estonia	Research Site	Tallinn
Germany	Research Site	Hildesheim
Germany	Research Site	Köln
Germany	Research Site	Magdeburg
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Poland	Research Site	Gdynia
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Yaroslavl
Serbia	Research Site	Belgrade
Serbia	Research Site	Niska Banja
South Africa	Research Site	Durban
Spain	Research Site	Barcelona
Spain	Research Site	Santiago de Compostela
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lutsk
Ukraine	Research Site	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Chile,  Colombia,  Czech Republic,  Estonia,  Germany,  Hungary,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in disease activity score	DAS28(CRP)	12 weeks	No
Primary	Proportion of subjects showing an improvement	ACR critieria	Week 24	No
Secondary	Safety and Tolerability	Incidence of adverse events (AEs) and serious adverse events (SAEs). Laboratory measurements, vital signs, PFTs and dysnoea scores	Informed consent through to end of subject participation in the study, approximately 40 weeks	Yes
Secondary	The response rates acheived at each visit	ACR20, ACR50, ACR70, ACRn, DAS28 Eular response	Biweekly for 24 weeks	No
Secondary	Effect of Mavrilimumab on Pain and Fatigue	Using patient reported outcomes, patiemt assessment of pain and FACIT-fatigue	24 Weeks	No
Secondary	Pharmacokinetics (PK)	Mavrilimumab serum concentrations	Day 1 to Week 24	Yes
Secondary	Immunogenicity (IM)	Number of subjects with anti-drug antibodies against mavrilimumab	Day 1 to Week 24	Yes
Secondary	Remission and low diease activity rates	DAS28	24 weeks	No