A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005648-93-EE

Enrollment

400

Registered

2012-04-16

Start date

2012-07-19

Completion date

Unknown

Last updated

2016-04-11

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: •Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization. •No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: •Subjects who have been permanently discontinued from investigational product in previous qualifying study. •Any new conditions or worsening of any pre-existing conditions as defined in the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study.;Secondary Objective: Evaluation of clinical effiacy and patient reported outcomes, pharmacodynamic effects and immunogenicity.;Primary end point(s): Long-term safety;Timepoint(s) of evaluation of this end point: At protocol-scheduled evaluation visits, up to 5 years, commercial availability or discontinuation of development, whichever is sooner.	—

Measure

Time frame

Main Objective: To evaluate the long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study.;Secondary Objective: Evaluation of clinical effiacy and patient reported outcomes, pharmacodynamic effects and immunogenicity.;Primary end point(s): Long-term safety;Timepoint(s) of evaluation of this end point: At protocol-scheduled evaluation visits, up to 5 years, commercial availability or discontinuation of development, whichever is sooner.

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Countries

Argentina, Bulgaria, Chile, Czech Republic, Estonia, France, Germany, Greece, Hungary, Mexico, Portugal, Russian Federation, Serbia, South Africa, Spain, Ukraine, United Kingdom

Outcome results

None listed

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