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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01706926
• Date of registration: 03/10/2012
• Prospective Registration: No
• Primary sponsor: MedImmune LLC
• Public title: A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
• 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: August 2012
• Target sample size: 420
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01706926
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Marius Albulescu, MD
• Affiliation: MedImmune Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

- A diagnosis of adult onset Rheumatoid Arthritis (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 disease-modifying anti-rheumatic drugs
(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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Mavrilimumab 30 mg

Other: Placebo

Biological: Mavrilimumab 100 mg

Biological: Mavrilimumab 150 mg

Primary Outcome(s)

Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85 [Time Frame: Baseline and Day 85]

Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 [Time Frame: Day 169]

Secondary Outcome(s)

Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 [Time Frame: Baseline up to Day 169]

Oxygen Saturation Level at Day 169 [Time Frame: Day 169]

Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit [Time Frame: Day 1 to Day 169]

Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 [Time Frame: Day 169]

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 [Time Frame: Day 169]

Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 [Time Frame: Day 169]

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: Baseline up to Day 169]

Mean Change From Baseline in Patient Assessment of Pain at Day 169 [Time Frame: Baseline and Day 169]

Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 [Time Frame: Baseline and Day 169]

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline up to Day 169]

Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 [Time Frame: Day 169]

Dyspnea Score at Day 169 [Time Frame: Day 169]

Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline up to Day 169]

Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 [Time Frame: Day 169]

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169 [Time Frame: Baseline and Day 169]

Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 [Time Frame: Baseline and Day 169]

Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169 [Time Frame: Day 169]

Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 [Time Frame: Day 169]

Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169 [Time Frame: Baseline, Day 169]

Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 [Time Frame: Baseline and Day 169]

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169 [Time Frame: Day 169]

Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169 [Time Frame: Baseline, Day 169]

Serum Concentrations of Mavrilimumab [Time Frame: Baseline, Day 8, 15, 29, 85, 141, and 169]

Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 [Time Frame: Baseline and Day 169]

Secondary ID(s)

CD-IA-CAM-3001-1071

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MedImmune Ltd

Results

• Results available: Yes
• Date Posted: 27/09/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01706926