NCT01706926

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2012

Geographic Reach
13 countries

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

October 3, 2012

Results QC Date

May 31, 2016

Last Update Submit

August 3, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisMavrilimumabCAM-3001

Outcome Measures

Primary Outcomes (2)

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

    DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, greater than or equal to (\>=) 3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.

    Baseline and Day 85

  • Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169

    ACR20 was defined as \>=20 percent (%) improvement, in: SJC and TJC and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.

    Day 169

Secondary Outcomes (24)

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Baseline up to Day 169

  • Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

    Baseline up to Day 169

  • Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

    Baseline up to Day 169

  • Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169

    Day 169

  • Dyspnea Score at Day 169

    Day 169

  • +19 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram \[mg\] per week) through oral or parenteral route.

Other: Placebo

Mavrilimumab 30 mg

EXPERIMENTAL

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Biological: Mavrilimumab 30 mg

Mavrilimumab 100 mg

EXPERIMENTAL

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Biological: Mavrilimumab 100 mg

Mavrilimumab 150 mg

EXPERIMENTAL

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Biological: Mavrilimumab 150 mg

Interventions

Mavrilimumab 30 mgBIOLOGICAL

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks

Also known as: CAM-3001
Mavrilimumab 30 mg
Mavrilimumab 100 mgBIOLOGICAL

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.

Also known as: CAM-3001
Mavrilimumab 100 mg
Mavrilimumab 150 mgBIOLOGICAL

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.

Also known as: CAM-3001
Mavrilimumab 150 mg
PlaceboOTHER

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Research Site

Ciudad Autonoma de Buenos Aire, Argentina

Location

Research Site

Rosario, Argentina

Location

Research Site

San Miguel de Tucumán, Argentina

Location

Research Site

Plovdiv, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Santiago, Chile

Location

Research Site

Viña del Mar, Chile

Location

Research Site

Barranquilla, Colombia

Location

Research Site

Bogotá, Colombia

Location

Research Site

Bruntál, Czechia

Location

Research Site

Jihlava, Czechia

Location

Research Site

Ostrava - Trebovice, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Zlín, Czechia

Location

Research Site

Tallinn, Estonia

Location

Research Site

Cologne, Germany

Location

Research Site

Hildesheim, Germany

Location

Research Site

Magdeburg, Germany

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Gdynia, Poland

Location

Research Site

Grodzisk Mazowiecki, Poland

Location

Research Site

Katowice, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Wroclaw, Poland

Location

Research Site

Barnaul, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Yaroslavl, Russia

Location

Research Site

Belgrade, Serbia

Location

Research Site

Niška Banja, Serbia

Location

Research Site

Durban, South Africa

Location

Research Site

Barcelona, Spain

Location

Research Site

Santiago de Compostela, Spain

Location

Research Site

Donetsk, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Kiev, Ukraine

Location

Research Site

Lutsk, Ukraine

Location

Research Site

Vinnytsia, Ukraine

Location

Related Publications (1)

  • Burmester GR, McInnes IB, Kremer J, Miranda P, Korkosz M, Vencovsky J, Rubbert-Roth A, Mysler E, Sleeman MA, Godwood A, Sinibaldi D, Guo X, White WI, Wang B, Wu CY, Ryan PC, Close D, Weinblatt ME; EARTH EXPLORER 1 study investigators. A randomised phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal antibody, in the treatment of rheumatoid arthritis. Ann Rheum Dis. 2017 Jun;76(6):1020-1030. doi: 10.1136/annrheumdis-2016-210624. Epub 2017 Feb 17.

    PMID: 28213566DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

mavrilimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule

Results Point of Contact

Title
Marius Albulescu, Associate Medical Director
Organization
MedImmune, LLC
albulescum@medimmune.com
301-398-0000

Study Officials

  • Marius Albulescu, MD

    MedImmune Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 15, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

September 27, 2016

Results First Posted

September 27, 2016

Record last verified: 2016-08

Locations

PL(6)ZA(1)SE(2)ES(1)UA(5)DE(3)AR(3)CL(2)RU(6)BU(2)HU(2)CO(2)CZ(5)