NCT01288287

Brief Summary

To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 27, 2016

Completed
Last Updated

September 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

January 25, 2011

Results QC Date

September 29, 2015

Last Update Submit

August 5, 2016

Conditions

Arthritis,Rheumatoid

Keywords

Certolizumab pegolCimzia®

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points

    DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 \* √(TJC) + 0.28\* √(SJC) + 0.70\* ln(ESR) + 0.014\* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.

    Baseline (Week 0), 78 weeks

Secondary Outcomes (4)

  • Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks

    Baseline (Week 0), 78 weeks

  • Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline

    Baseline (Week 0), 78 weeks

  • Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks

    Baseline (Week 0), 78 weeks

  • Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks

    Baseline (Week 0), 78 weeks

Study Arms (2)

Week 12 Disease Activity Score (DAS) Responders

Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12

Week 12 Disease Activity Score (DAS) Non-Responders

Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic

You may qualify if:

  • Informed consent is signed and dated
  • The patient is considered capable of and prepared to adhere to the study protocol procedures
  • The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
  • The patient is screen-negative for tuberculosis
  • The patient is 18 years of age or above

You may not qualify if:

  • The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
  • Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
  • Patient has participated in another study within the last 30 days
  • Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
  • Patient has inadequate literacy to understand and complete the questionnaires.
  • Contraindications stated in the SmPC
  • Patient is pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

2

Cork, Cork, Ireland

Location

7

Bridgend, Bridgend, United Kingdom

Location

25

Cardiff, Cardiff, United Kingdom

Location

4

Durham, County Durham, United Kingdom

Location

17

Poole, Dorset, United Kingdom

Location

24

Eastbourne, East Sussex, United Kingdom

Location

13

Southend, Essex, United Kingdom

Location

11

Manchester, Greater Manchester, United Kingdom

Location

12

Manchester, Greater Manchester, United Kingdom

Location

6

Southampton, Hampshire, United Kingdom

Location

20

Gillingham, Kent, United Kingdom

Location

15

St Helens, Lancashire, United Kingdom

Location

10

Liverpool, Merseyside, United Kingdom

Location

22

Ashford, Middlesex, United Kingdom

Location

14

Abergavenny, Monmouthshire, United Kingdom

Location

5

Bath, Somerset, United Kingdom

Location

19

Burton, Staffordshire, United Kingdom

Location

3

Chertsey, Surrey, United Kingdom

Location

18

Birmingham, West Midlands, United Kingdom

Location

16

Cannock, West Midlands, United Kingdom

Location

9

Dudley, West Midlands, United Kingdom

Location

1

York, Yorkshire, United Kingdom

Location

Related Publications (1)

  • Kumar N, Naz S, Quinn M, Ryan J, Kumke T, Sheeran T. Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland. Adv Ther. 2018 Sep;35(9):1426-1437. doi: 10.1007/s12325-018-0758-1. Epub 2018 Aug 3.

    PMID: 30076523DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493 (UCB)

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

Study Record Dates

First Submitted

January 25, 2011

First Posted

February 2, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

September 16, 2016

Results First Posted

June 27, 2016

Record last verified: 2016-08

Locations

IE(1)GB(21)