Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors - Full Text View

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, Multinational, Noninterventional Study With Certolizumab Pegol in Comparison to Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Rheumatoid Arthritis

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

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) or local labeling.

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 local Summary of Product Characteristics (SmPC) or labeling instructions 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:	1814
Study Start Date:	December 2012
Estimated Study Completion Date:	July 2017
Estimated Primary Completion Date:	July 2017 (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) latest at Visit 1
Treatment is according to the Summary of Product Characteristics (SmPC) and local labeling

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

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

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Show 89 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:	April 23, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Austria: Federal Office for Safety in Health Care Bulgaria: Bulgarian Drug Agency Greece: National Organization of Medicines France: Committee for the Protection of Personnes France: Conseil National de l'Ordre des Médecins Finland: Finnish Medicines Agency Switzerland: Swissmedic Canada: Ethics Review Committee Romania: National Medicines Agency

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
Immunoglobulin Fab Fragments
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

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