Rheumatoid ArthritisPhase 3SWIFTNCT01292265
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
A Phase 3 study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Pharma at 6 sites in United States.
Trial summary
To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
- Active RA
- Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
- Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance
Who cannot join
- Subject cannot have a second non-inflammatory musculoskeletal condition
- Subject cannot have a diagnosis of any other inflammatory arthritis
- Subject cannot have any previously infected prosthesis
- Subject cannot have arthroplasties in any of the joints assessed in the study
- Subject cannot have a history of chronic infections
- Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
Show all 13Show fewer
- Subject cannot have a history of or current Lymphoproliferative disorder
- Subject cannot have known Human Immunodeficiency Virus (HIV) infection
- Subject cannot have received a live or attenuated vaccine within 8 weeks
- Subject cannot have current or history of malignancy
- Subject cannot have a history of blood disorders
- Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
- Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
7
Franklin, Wisconsin
10
Los Angeles, California
6
Rochester, New York
1
Voorhees Township, New Jersey
4
Walnut Creek, California
8
Wheaton, Maryland
About this study
Official title: A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol
To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
Read the detailed description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Certolizumab Pegol
- Keywords
- Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Arthralgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolBiological
Also called Cimzia, CZP
Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
| Study group | Role | What they receive |
|---|---|---|
| CZP 200 mg | Experimental | Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10. Receives: Biological: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Measured: From Baseline (Week 0) to Week 12
Secondary outcomes (3)
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Measured: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Measured: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Measured: From Baseline (Week 0) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Termination of study due to low enrollment. There were no safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292265
- Sponsor's protocol ID
- RA0033
- Acronym
- SWIFT
- Status last verified
- Oct 2012
- First submitted
- 7 Feb 2011
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol
- ClinicalTrials.gov ID
- NCT01292265
- Acronym / sponsor ID
- SWIFT / RA0033
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study due to low enrollment. There were no safety issues.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 5 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
Detailed description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CZP 200 mg | Experimental | Biological: Certolizumab PegolCertolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
- Active RA
- Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
- Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance
Key exclusion criteria (13 listed)
- Subject cannot have a second non-inflammatory musculoskeletal condition
- Subject cannot have a diagnosis of any other inflammatory arthritis
- Subject cannot have any previously infected prosthesis
- Subject cannot have arthroplasties in any of the joints assessed in the study
- Subject cannot have a history of chronic infections
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: Cimzia, CZPCertolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10. | Biological | CZP 200 mg |
Primary outcome
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Time frame: From Baseline (Week 0) to Week 12
3 secondary outcomes
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Rheumatoid Arthritis
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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
6 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 UCB Pharma at 6 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 13 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: stopped early, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 5 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12 (time frame: From Baseline (Week 0) to Week 12). 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 1 Aug 2018.