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

The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01213017

Acronym

PICS

Enrollment

Registered

2010-10-01

Start date

2010-09-30

Completion date

2012-04-30

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3

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.

Interventions

DRUGcertolizumab pegol

400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026