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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01443364
Date of registration:	27/09/2011
Prospective Registration:	Yes
Primary sponsor:	UCB Italy s.p.a.
Public title:	Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis SPEED
Scientific 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)
Date of first enrolment:	December 2011
Target sample size:	132
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01443364
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Italy

Contacts

Name:	UCB Clinical Trial Call Center
Address:
Telephone:
Email:
Affiliation:	+1 877 822 9493 (UCB)

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Certolizumab pegol

Primary Outcome(s)

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]

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]

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]

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]

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]

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]

Secondary Outcome(s)

Bone Erosion at Week 0 [Time Frame: Week 0 (Baseline)]

Bone Erosion at Week 12 [Time Frame: Week 12]

Bone Erosion at Week 52 [Time Frame: Week 52]

Cartilage Damage at Week 2 [Time Frame: Week 2]

Cartilage Damage at Week 24 [Time Frame: Week 24]

Cartilage Damage at Week 8 [Time Frame: Week 8]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 [Time Frame: From Baseline to Week 6]

Change From Baseline in the Bone Erosion at Week 36 [Time Frame: From Baseline to Week 36]

Change From Baseline in the Bone Erosion at Week 52 [Time Frame: From Baseline to Week 52]

Change From Baseline in the Cartilage Damage at Week 52 [Time Frame: From Baseline to Week 52]

Change From Baseline in the Doppler Signal and Blood Flow at Week 36 [Time Frame: From Baseline to Week 36]

Doppler Signal and Blood Flow at Week 52 [Time Frame: Week 52]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 [Time Frame: Week 12]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 [Time Frame: Week 24]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 [Time Frame: Week 36]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 [Time Frame: Week 52]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 [Time Frame: Week 1]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 [Time Frame: Week 2]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 [Time Frame: Week 24]

Cartilage Damage at Week 4 [Time Frame: Week 4]

Cartilage Damage at Week 6 [Time Frame: Week 6]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 [Time Frame: Week 36]

Synovial Fluid and Proliferation at Week 12 [Time Frame: Week 12]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 [Time Frame: From Baseline to Week 36]

Change From Baseline in the Bone Erosion at Week 1 [Time Frame: From Baseline to Week 1]

Change From Baseline in the Cartilage Damage at Week 24 [Time Frame: From Baseline to Week 24]

Change From Baseline in the Cartilage Damage at Week 6 [Time Frame: From Baseline to Week 6]

Change From Baseline in the Doppler Signal and Blood Flow at Week 4 [Time Frame: From Baseline to Week 4]

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]

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]

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]

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]

Change From Baseline in the Synovial Fluid and Proliferation at Week 12 [Time Frame: From Baseline to Week 12]

Change From Baseline in the Synovial Fluid and Proliferation at Week 36 [Time Frame: From Baseline to Week 36]

Change From Baseline in the Synovial Fluid and Proliferation at Week 8 [Time Frame: From Baseline to Week 8]

Doppler Signal and Blood Flow at Week 36 [Time Frame: Week 36]

Doppler Signal and Blood Flow at Week 6 [Time Frame: Week 6]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 [Time Frame: Week 4]

Synovial Fluid and Proliferation at Week 8 [Time Frame: Week 8]

Cartilage Damage at Week 36 [Time Frame: Week 36]

Cartilage Damage at Week 52 [Time Frame: Week 52]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 [Time Frame: From Baseline to Week 1]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 [Time Frame: From Baseline to Week 24]

Change From Baseline in the Cartilage Damage at Week 4 [Time Frame: From Baseline to Week 4]

Change From Baseline in the Doppler Signal and Blood Flow at Week 24 [Time Frame: From Baseline to Week 24]

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]

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]

Change From Baseline in the Synovial Fluid and Proliferation at Week 24 [Time Frame: From Baseline to Week 24]

Doppler Signal and Blood Flow at Week 0 [Time Frame: Week 0 (Baseline)]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 [Time Frame: Week 6]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 [Time Frame: Week 12]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 [Time Frame: Week 52]

Synovial Fluid and Proliferation at Week 6 [Time Frame: Week 6]

Bone Erosion at Week 24 [Time Frame: Week 24]

Cartilage Damage at Week 0 [Time Frame: Week 0 (Baseline)]

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]

Change From Baseline in the Synovial Fluid and Proliferation at Week 52 [Time Frame: From Baseline to Week 52]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 [Time Frame: Week 2]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 [Time Frame: Week 0 (Baseline)]

Bone Erosion at Week 4 [Time Frame: Week 4]

Cartilage Damage at Week 1 [Time Frame: Week 1]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 [Time Frame: From Baseline to Week 12]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 [Time Frame: From Baseline to Week 2]

Change From Baseline in the Bone Erosion at Week 12 [Time Frame: From Baseline to Week 12]

Change From Baseline in the Bone Erosion at Week 6 [Time Frame: From Baseline to Week 6]

Change From Baseline in the Cartilage Damage at Week 8 [Time Frame: From Baseline to Week 8]

Change From Baseline in the Doppler Signal and Blood Flow at Week 2 [Time Frame: From Baseline to Week 2]

Change From Baseline in the Doppler Signal and Blood Flow at Week 6 [Time Frame: From Baseline to Week 6]

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]

Doppler Signal and Blood Flow at Week 1 [Time Frame: Week 1]

Doppler Signal and Blood Flow at Week 8 [Time Frame: Week 8]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 [Time Frame: Week 4]

Synovial Fluid and Proliferation at Week 36 [Time Frame: Week 36]

Bone Erosion at Week 1 [Time Frame: Week 1]

Bone Erosion at Week 2 [Time Frame: Week 2]

Bone Erosion at Week 36 [Time Frame: Week 36]

Bone Erosion at Week 6 [Time Frame: Week 6]

Bone Erosion at Week 8 [Time Frame: Week 8]

Cartilage Damage at Week 12 [Time Frame: Week 12]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 [Time Frame: From Baseline to Week 8]

Change From Baseline in the Cartilage Damage at Week 2 [Time Frame: From Baseline to Week 2]

Change From Baseline in the Cartilage Damage at Week 36 [Time Frame: From Baseline to Week 36]

Change From Baseline in the Doppler Signal and Blood Flow at Week 1 [Time Frame: From Baseline to Week 1]

Change From Baseline in the Synovial Fluid and Proliferation at Week 4 [Time Frame: From Baseline to Week 4]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 [Time Frame: Week 8]

Synovial Fluid and Proliferation at Week 4 [Time Frame: Week 4]

Change From Baseline in the Bone Erosion at Week 8 [Time Frame: From Baseline to Week 8]

Change From Baseline in the Cartilage Damage at Week 1 [Time Frame: From Baseline to Week 1]

Change From Baseline in the Cartilage Damage at Week 12 [Time Frame: From Baseline to Week 12]

Change From Baseline in the Doppler Signal and Blood Flow at Week 12 [Time Frame: From Baseline to Week 12]

Change From Baseline in the Synovial Fluid and Proliferation at Week 1 [Time Frame: From Baseline to Week 1]

Change From Baseline in the Synovial Fluid and Proliferation at Week 2 [Time Frame: From Baseline to Week 2]

Doppler Signal and Blood Flow at Week 12 [Time Frame: Week 12]

Doppler Signal and Blood Flow at Week 4 [Time Frame: Week 4]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0 [Time Frame: Week 0 (Baseline)]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 [Time Frame: Week 1]

Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 [Time Frame: Week 8]

Synovial Fluid and Proliferation at Week 2 [Time Frame: Week 2]

Synovial Fluid and Proliferation at Week 52 [Time Frame: Week 52]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 [Time Frame: From Baseline to Week 4]

Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 [Time Frame: From Baseline to Week 52]

Change From Baseline in the Bone Erosion at Week 2 [Time Frame: From Baseline to Week 2]

Change From Baseline in the Bone Erosion at Week 24 [Time Frame: From Baseline to Week 24]

Change From Baseline in the Bone Erosion at Week 4 [Time Frame: From Baseline to Week 4]

Change From Baseline in the Doppler Signal and Blood Flow at Week 52 [Time Frame: From Baseline to Week 52]

Change From Baseline in the Doppler Signal and Blood Flow at Week 8 [Time Frame: From Baseline to Week 8]

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]

Change From Baseline in the Synovial Fluid and Proliferation at Week 6 [Time Frame: From Baseline to Week 6]

Doppler Signal and Blood Flow at Week 2 [Time Frame: Week 2]

Doppler Signal and Blood Flow at Week 24 [Time Frame: Week 24]

Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 [Time Frame: Week 6]

Synovial Fluid and Proliferation at Week 0 [Time Frame: Week 0 (Baseline)]

Synovial Fluid and Proliferation at Week 1 [Time Frame: Week 1]

Synovial Fluid and Proliferation at Week 24 [Time Frame: Week 24]

Secondary ID(s)

RA0069

2011-000385-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	23/03/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01443364

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