Clinical trial NCT01706926: A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Official title: A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Mavrilimumab
CAM-3001
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: MedImmune Ltd
First posted: 2012-10-15
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Detailed description: Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85
timeFrame: Baseline and Day 85
measure: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
timeFrame: Day 169
Secondary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline up to Day 169
measure: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 169
measure: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 169
measure: Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169
timeFrame: Day 169
measure: Dyspnea Score at Day 169
timeFrame: Day 169
measure: Oxygen Saturation Level at Day 169
timeFrame: Day 169
measure: Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
timeFrame: Day 169
measure: Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
timeFrame: Day 169
measure: Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
timeFrame: Baseline up to Day 169
measure: Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
timeFrame: Day 169
measure: Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
timeFrame: Day 169
measure: Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
timeFrame: Baseline and Day 169
measure: Mean Change From Baseline in Patient Assessment of Pain at Day 169
timeFrame: Baseline and Day 169
measure: Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
timeFrame: Baseline and Day 169
measure: Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
timeFrame: Baseline and Day 169
measure: Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
timeFrame: Baseline and Day 169
measure: Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169
timeFrame: Baseline, Day 169
measure: Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169
timeFrame: Baseline, Day 169
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169
timeFrame: Day 169
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
timeFrame: Day 169
measure: Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
timeFrame: Day 169
measure: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169
timeFrame: Baseline and Day 169
measure: Serum Concentrations of Mavrilimumab
timeFrame: Baseline, Day 8, 15, 29, 85, 141, and 169
measure: Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit
timeFrame: Day 1 to Day 169
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Vina del Mar
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bruntal
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Ostrava - Trebovice
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Marius Albulescu, MD
role: STUDY_DIRECTOR
References: