Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol

NCT01526434 | Completed

• 2 other identifiers: RA0053UCB-CER-2010-01
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 15

Brief Summary

The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).

Conditions

Rheumatoid Arthritis

Keywords

Cimzia; Non-interventional; Multicenter; Postmarketing; Local

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

  The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.

  From Baseline (Week 0) to Week 12

• Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)

  An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.

  From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

• Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)

  A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.

  From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

• Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)

  An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.

  From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

Secondary Outcomes (24)

• Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12

  From Baseline (Week 0) to Week 12

• Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12

  From Baseline (Week 0) to Week 12

• Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12

  From Baseline (Week 0) to Week 12

• Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12

  From Baseline (Week 0) to Week 12

• Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12

  From Baseline (Week 0) to Week 12

Study Arms (1)

Certolizumab Pegol treatment

Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol.

Eligibility Criteria

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

Study Population

Patients with RA who begin therapy with CZP will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the study protocol. The study will include approximately 105 patients from 20 to 25 sites in Spain.

You may qualify if:

• Patient is male or female, aged 18 years or older
• Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
• Patient has DAS28 (ESR) \> 4.5 and CRP \> 1.0 mg/dl at Baseline
• Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
• Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
• Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
• Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
• Patient has signed and dated a written informed consent form
• The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)

You may not qualify if:

• Patient has a known hypersensitivity to the active substance or to any of the excipients
• Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
• Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
• Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
• Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy

Sponsors & Collaborators

• UCB Pharma SA: lead
• ReSearch Pharmaceutical Services, Inc.: collaborator

Study Sites (15)

11

A Coruña, Spain

Location

15

Barcelona, Spain

Location

20

Barcelona, Spain

Location

4

Barcelona, Spain

Location

7

Barcelona, Spain

Location

21

Girona, Spain

Location

9

Granada, Spain

Location

12

León, Spain

Location

17

Lleida, Spain

Location

18

Lleida, Spain

Location

6

Salamanca, Spain

Location

10

Seville, Spain

Location

14

Tarragona, Spain

Location

16

Tarragona, Spain

Location

5

Vigo, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

ES (15)