Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors (NexT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01764321
First received: January 7, 2013
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Noninterventional Study With Certolizumab Pegol in Comparison With Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment [ Time Frame: up to Week 104 ] [ Designated as safety issue: No ]

    For a patient to be classified as persistent he or she must be classified as an early responder up to Week 12 and be continuously treated up to Week 104 with the initially prescribed Tumor Necrosis Factor (TNF) inhibitor at a dose not greater than that initially prescribed according to the Summary of Product Characteristics (SmPC).

    For the definition of persistence rate for the primary variable, patients will be classified as early responders if their Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) shows a reduction of ≥ 1.2 from Baseline or decreases to ≤ 3.2 (Low Disease Activity (LDA) or remission) up to Week 12.

    Non responders up to Week 12 will be counted as non persistent to the initially prescribed TNF inhibitor treatment.

    Patients who stop the initially prescribed TNF inhibitor treatment will not be counted as persistent, except if treatment with TNF inhibitor is stopped because the patient is in clinical remission.



Secondary Outcome Measures:
  • Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) reduction of ≥ 1.2 or DAS28 (ESR) decrease to ≤ 3.2 up to Week 12 [ Time Frame: From Baseline up to Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving early clinical response to treatment based on DAS28 (ESR) reduction of ≥ 1.2 or DAS28 (ESR) decrease to ≤ 3.2, and being in DAS28 (ESR) remission or Low Disease Activity (LDA) at Week 104 [ Time Frame: From Baseline up to Week 12 and to Week 104 ] [ Designated as safety issue: No ]
    • LDA is defined as DAS28 (ESR) ≤ 3.2
    • DAS28 (ESR) is defined as Disease Activity Score 28 (Erythrocyte Sedimentation Rate)

  • Proportion of patients not achieving early clinical response to treatment based on DAS28 (ESR) reduction of ≥ 1.2 or DAS28 (ESR) decrease to ≤ 3.2, and being in DAS28 (ESR) remission or Low Disease Activity (LDA) at Week 104 [ Time Frame: From Baseline up to Week 12 and to Week 104 ] [ Designated as safety issue: No ]
    • LDA is defined as DAS28 (ESR) ≤ 3.2
    • DAS28 (ESR) is defined as Disease Activity Score 28 (Erythrocyte Sedimentation Rate)

  • Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) reduction of ≥ 1.2 up to Week 12 [ Time Frame: From Baseline up to Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) reduction of ≥ 1.2, and being in DAS28 (ESR) remission or Low Disease Activity (LDA) at Week 104 [ Time Frame: From Baseline up to Week 12 and to Week 104 ] [ Designated as safety issue: No ]
    Low Disease Activity (LDA) is defined as DAS28 (ESR) ≤ 3.2

  • Proportion of patients not achieving early clinical response to treatment based on Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) reduction of ≥ 1.2, and being in DAS28(ESR) remission or Low Disease Activity (LDA) at Week 104 [ Time Frame: From Baseline up to Week 12 and to Week 104 ] [ Designated as safety issue: No ]
    Low Disease Activity (LDA) is defined as DAS28 (ESR) ≤ 3.2

  • Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to lack/loss of efficacy during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to Adverse Events (AEs) during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to any other reasons during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment at the dose recommended according to the Summary of Product Characteristics (SmPC) during the duration of the study [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to lack/loss of efficacy during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to Adverse Events (AEs) during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]
  • Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to any other reasons during the duration of the study (up to Week 104) [ Time Frame: From Baseline up to Week 104 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1360
Study Start Date: December 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Certolizumab Pegol treatment
Certolizumab Pegol in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)
Other Tumor Necrosis Factor TNF inhibitor treatment
Other subcutaneous (sc) Tumor Necrosis Factor (TNF) inhibitor (Adalimumab, Golimumab, Etanercept) in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with diagnosed Rheumatoid Arthritis (RA)

Criteria

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA)
  • Moderate to severe disease activity of RA
  • The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD)
  • The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS)
  • Male or female patients ≥ 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires)
  • The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2
  • Treatment is according to the Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • Known contraindications to Tumor Necrosis Factor (TNF) inhibitors
  • Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra)
  • Participation in an investigational study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764321

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 139 Study Locations
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01764321     History of Changes
Other Study ID Numbers: RA0097
Study First Received: January 7, 2013
Last Updated: August 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Certolizumab Pegol
Cimzia®
TNF inhibitor
DMARD
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on August 27, 2014