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.

• Register: EUCTR
• Last refreshed on: 25 February 2013
• Main ID: EUCTR2011-005634-19-HU
• Date of registration: 11/04/2012
• Prospective Registration: Yes
• Primary sponsor: MedImmune Ltd
• Public title: 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.
• Scientific title: A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.
• Date of first enrolment: 30/05/2012
• Target sample size: 280
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005634-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4

Countries of recruitment

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

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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 unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12 and Week 24.

Secondary Objective: To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.

Main Objective: To evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset 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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: As specified by the protocol (Table 5.1-1)

Secondary end point(s): To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.

Secondary ID(s)

CD-IA-CAM-3001-1071