The Effect of Certolizumab Pegol on MRI Synovitis and Bon... | NCT01213017

Studies
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

NCT01213017

Sponsor

Oklahoma Medical Research Foundation

Status

Completed

Last Update Posted

Dec 7, 2017Actual

Enrollment

20Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

certolizumab pegol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 29, 2010

First Submission Date that Met QC Criteria

Sep 29, 2010

First Posted Date

Oct 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.

Detailed Description

The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Certolizumab pegol	Experimental		Drug: certolizumab pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
certolizumab pegol	Drug	400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks	Certolizumab pegol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the change from baseline in synovitis and bone edema RAMRIS score.		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
the change from baseline in RAMRIS erosion score		16 and 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

moderate to severe RA (DAS > 4.4)
at least two swollen and tender joints in one of the hand/ wrist
patients must have failed at least one non-biologic or biologic DMARDs
currently receiving MTX therapy

Exclusion Criteria:

concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ewa Olech, MD	Oklahoma Medical Research Foundation	Principal Investigator
Norman B Gaylis, MD	Arthritis and Rheumatic Disease Specialties	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis and Rheumatic Disease Specialties		Aventura	Florida	33180	United States
Oklahoma Medical Research Foundation

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make individual participant data available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments

Browse Leaves

Not provided

Browse Branches

Not provided