A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005634-19-HU

Enrollment

280

Registered

2012-04-11

Start date

2012-05-30

Completion date

Unknown

Last updated

2013-02-25

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

Conditions

Rheumatoid arthritis MedDRA version: 14.1 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 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 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 252 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.;Secondary Objective: To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.;Primary end point(s): Change from Day 1 score at Week 12 (assessment 1) and Week 24 (assessment 2) in protocol-defined assessments of RA efficacy.;Timepoint(s) of evaluation of this end point: Week 12 and Week 24.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.;Secondary Objective: To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.;Primary end point(s): Change from Day 1 score at Week 12 (assessment 1) and Week 24 (assessment 2) in protocol-defined assessments of RA efficacy.;Timepoint(s) of evaluation of this end point: Week 12 and Week 24.

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.;Timepoint(s) of evaluation of this end point: As specified by the protocol (Table 5.1-1)	—

Countries

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

Outcome results

None listed

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