Rheumatoid ArthritisPhase 3PICSNCT01213017
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
A Phase 3 study testing certolizumab pegol in people with Rheumatoid Arthritis, run by Oklahoma Medical Research Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- certolizumab pegol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- certolizumab pegol
- Keywords
- Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certolizumab pegolDrug
Also called Cimzia
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab pegol | Experimental | Not described Receives: Drug: certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in synovitis and bone edema RAMRIS score.
Measured: 6 weeks
Secondary outcomes (1)
the change from baseline in RAMRIS erosion score
Measured: 16 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Ewa Olech, MD, Principal investigator, Oklahoma Medical Research FoundationNorman B Gaylis, MD, Principal investigator, Arthritis and Rheumatic Disease Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213017
- Sponsor's protocol ID
- OMRF-UCB-5-16-2010
- Acronym
- PICS
- Status last verified
- Dec 2017
- First submitted
- 29 Sep 2010
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01213017
- Acronym / sponsor ID
- PICS / OMRF-UCB-5-16-2010
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oklahoma Medical Research FoundationUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol | Experimental | Drug: certolizumab pegol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| certolizumab pegolAlso: Cimzia400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks | Drug | Certolizumab pegol |
Primary outcome
the change from baseline in synovitis and bone edema RAMRIS score.
Time frame: 6 weeks
1 secondary outcome
the change from baseline in RAMRIS erosion score
Time frame: 16 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Olech, MD principal investigator
Oklahoma Medical Research Foundation
Norman B Gaylis, MD principal investigator
Arthritis and Rheumatic Disease Specialties
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing certolizumab pegol in people with Rheumatoid Arthritis, run by Oklahoma Medical Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline in synovitis and bone edema RAMRIS score. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.