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

NCT01443364 | Completed Phase 4 Results

• 2 other identifiers: RA00692011-000385-35
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab pegol - Cimzia; Rheumatoid Arthritis; Power Doppler Ultrasonography; Italy; Moderate-severe Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52

  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

  From Baseline to Week 12 and Week 52

• The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52

  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

  From Baseline to Week 8 and Week 52

• The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52

  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

  From Baseline to Week 6 and Week 52

• The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52

  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

  From Baseline to Week 4 and Week 52

• The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52

  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

  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

  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

  From Baseline to Week 1 and Week 52

Secondary Outcomes (114)

• Change From Baseline in the Synovial Fluid and Proliferation at Week 52

  From Baseline to Week 52

• Change From Baseline in the Synovial Fluid and Proliferation at Week 36

  From Baseline to Week 36

• Change From Baseline in the Synovial Fluid and Proliferation at Week 24

  From Baseline to Week 24

• Change From Baseline in the Synovial Fluid and Proliferation at Week 12

  From Baseline to Week 12

• Change From Baseline in the Synovial Fluid and Proliferation at Week 8

  From Baseline to Week 8

Study Arms (1)

Certolizumab pegol

EXPERIMENTAL

Biological: Certolizumab pegol

Interventions

Certolizumab pegol BIOLOGICAL

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.

Also known as: CIMZIA, CZP

Certolizumab pegol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Italy s.p.a.: lead

Study Sites (18)

11

Bari, Italy

Location

08

Catania, Italy

Location

10

Ferrara, Italy

Location

12

Florence, Italy

Location

01

Iesi, Italy

Location

05

Milan, Italy

Location

13

Milan, Italy

Location

18

Milan, Italy

Location

07

Modena, Italy

Location

23

Monserrato, Italy

Location

20

Napoli, Italy

Location

16

Padua, Italy

Location

06

Roma, Italy

Location

21

Roma, Italy

Location

22

Siena, Italy

Location

09

Torino, Italy

Location

04

Udine, Italy

Location

02

Verona, Italy

Location

Related Publications (1)

• Sarzi-Puttini P, Filippucci E, Adami S, Meroni PL, Batticciotto A, Idolazzi L, De Lucia O, Talavera P, Kumke T, Grassi W. Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study. Adv Ther. 2018 Aug;35(8):1153-1168. doi: 10.1007/s12325-018-0751-8. Epub 2018 Jul 24.

  PMID: 30043210 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1877 822

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 15, 2017
• Results First Posted: March 23, 2016

Record last verified: 2017-07

Locations

IT (18)