NCT01652937

Brief Summary

Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 16, 2013

Status Verified

October 1, 2012

Enrollment Period

1.5 years

First QC Date

July 19, 2012

Last Update Submit

September 12, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisDMARD-IR

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)

    Week 12

Secondary Outcomes (3)

  • Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study

    Up to 16 weeks

  • Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32

    Week 12

  • Proportion of subjects achieving ACR50 and ACR70 response

    Week 12

Study Arms (4)

Placebo + Background Therapy

PLACEBO COMPARATOR

Background therapy including DMARD(s) approved by protocol

Drug: Placebo

BIIB057 Dose 1 + Background Therapy

EXPERIMENTAL

Background therapy including DMARD(s) approved by protocol

Drug: BIIB057

BIIB057 Dose 2 + Background Therapy

EXPERIMENTAL

Background therapy including DMARD(s) approved by protocol

Drug: BIIB057

BIIB057 Dose 3 + Background Therapy

EXPERIMENTAL

Background therapy including DMARD(s) approved by protocol

Drug: BIIB057

Interventions

BIIB057DRUG

Oral

BIIB057 Dose 1 + Background TherapyBIIB057 Dose 2 + Background TherapyBIIB057 Dose 3 + Background Therapy
PlaceboDRUG

Oral

Placebo + Background Therapy

Eligibility Criteria

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

You may qualify if:

  • Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
  • Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
  • No prior treatment with biologics
  • Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening

You may not qualify if:

  • History of inflammatory joint disease other than RA
  • Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
  • History of malignancy, carcinoma in situ, or high-grade dysplasia
  • History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
  • Clinically significant cardiac disease
  • Treatment with prednisone \>10 mg orally daily
  • Intra-articular steroid injection within 28 days before screening
  • Clinically significant abnormality in hematology or blood chemistry values at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Winnipeg, Manitoba, R3C 3J5, Canada

Location

Research Site

Quispamsis, New Brunswick, E2E 4J8, Canada

Location

Research Site

Toronto, Ontario, M9W 4L6, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
0

Study Design

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

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 30, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

September 16, 2013

Record last verified: 2012-10

Locations

CA(3)