Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (SPEED)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01443364
First received: September 27, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Certolizumab pegol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The percentage of subjects with clinical response at Week 12 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 12 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  • The percentage of subjects with clinical response at Week 8 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 8 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  • The percentage of subjects with clinical response at Week 6 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 6 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  • The percentage of subjects with clinical response at Week 4 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 4 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  • The percentage of subjects with clinical response at Week 2 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 2 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  • The percentage of subjects with clinical response at Week 1 who also had clinical response at Week 52 [ Time Frame: From Baseline to Week 1 and Week 52 ] [ Designated as safety issue: No ]
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system


Secondary Outcome Measures:
  • Change from Baseline in the synovial fluid and proliferation at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the synovial fluid and proliferation at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Doppler signal and blood flow at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the Cartilage damage at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the Cartilage damage at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the bone erosion at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36 [ Time Frame: From Baseline to Week 36 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6 [ Time Frame: From Baseline to Week 6 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1 [ Time Frame: From Baseline to Week 1 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Synovial fluid and proliferation at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Synovial fluid and proliferation at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Doppler signal and blood flow at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.

  • Cartilage damage at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Cartilage damage at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Bone erosion at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the synovial fluid volume and hypertrophy score at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.

  • Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 0 [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol Biological: Certolizumab pegol
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
Other Names:
  • CIMZIA
  • CZP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
  • positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
  • active RA disease
  • subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
  • subject is naïve to RA related biologics

Exclusion Criteria:

  • a diagnosis of any other inflammatory arthritis
  • history of infected joint prosthesis, or other significant infection
  • known Tuberculosis (TB) disease or high risk of acquiring TB infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443364

Locations
Italy
11
Bari, Italy
08
Catania, Italy
10
Ferrara, Italy
12
Firenze, Italy
01
Jesi, Italy
05
Milano, Italy
13
Milano, Italy
18
Milano, Italy
07
Modena, Italy
23
Monserrato, Italy
20
Napoli, Italy
16
Padova, Italy
03
Pisa, Italy
14
Potenza, Italy
06
Roma, Italy
21
Roma, Italy
22
Siena, Italy
09
Torino, Italy
04
Udine, Italy
02
Verona, Italy
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01443364     History of Changes
Other Study ID Numbers: RA0069, 2011-000385-35
Study First Received: September 27, 2011
Last Updated: March 7, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by UCB, Inc.:
Certolizumab pegol - Cimzia
Rheumatoid Arthritis
Power Doppler Ultrasonography
Italy
Moderate-severe Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014