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.

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005649-10-DE

Enrollment

120

Registered

2012-07-18

Start date

2013-08-19

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: mavrilimumab Product Code: CAM-3001 Pharmaceutical Form: Solution for injection INN or Proposed INN: mavrilimumab CAS Number: 1085337-57-0 Current Sponsor code: CAM-3001 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • A diagnosis of at least moderately-active adult onset RA. • Inadequate response to one or more conventional DMARDs and/or 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the efficacy of mavrilimumab compared to an anti-TNF antibody in adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two other anti-TNF agents.;Secondary Objective: Evaluation of safety tolerability, pharmacokinetic effects and immunogenicity of mavrilimumab.;Primary end point(s): Established endpoints of RA efficacy, as defined in the protocol.;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: To explore the efficacy of mavrilimumab compared to an anti-TNF antibody in adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two other anti-TNF agents.;Secondary Objective: Evaluation of safety tolerability, pharmacokinetic effects and immunogenicity of mavrilimumab.;Primary end point(s): Established endpoints of RA efficacy, as defined in the protocol.;Timepoint(s) of evaluation of this end point: Week 24

—

Secondary

Measure	Time frame
Secondary end point(s): Safety and tolerability via assessment of AEs and SAEs. Assessment of PK and IM parameters, as defined in the protocol.;Timepoint(s) of evaluation of this end point: 36 weeks (24 weeks treatment + 12 weeks Safety Follow-up)	—

Countries

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

Contacts

Public ContactClinical Trial Enquiries

MedImmune Ltd

clinicaltrialenquiries@medimmune.com4401223471471

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026