Psoriatic ArthritisPhase 3STEREONCT00235885
Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA)
A Phase 3 study testing adalimumab in people with Psoriatic Arthritis, run by Abbott at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- adalimumab
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to not given
- 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
- Males and females > 18 years of age
- Active PsA with > 3 tender and > 3 swollen joints despite standard therapy
- Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
- A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
- Use of a reliable method of contraception by all female patients of childbearing potential
- Able and willing to self-administer sc injections or have a suitable person to administer sc injections
- Able and willing to give written informed consent and comply with the protocol
Who cannot join
- Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
- Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
- Treatment within last 4 weeks with a combination of MTX and leflunomide
- Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
- History of or current active acute inflammatory joint disease of origin other than PsA
Show all 15Show fewer
- Comorbidities (uncontrolled diabetes, unstable ischemic heart disease, CHF, active IBD, stroke within 3 months, chronic leg ulcer and other condition which would put subject at risk by participation in the protocol
- Positive serology for hepatitis B or C
- History of positive HIV status
- Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
- Females who are pregnant or breast-feeding
- History of clinically significant drug or alcohol abuse in the last year
- Previous diagnosis or signs of central nervous system demyelinating diseases
- History of tuberculosis, histoplasmosis or listeriosis
- Subjects with latent TB or having other risk factors for activation of latent TB who have not initiated a TB prophylaxis prior to the first adalimumab treatment .
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information - Abbott
Abbott Park, Illinois, 60064
About this study
Official title: Safety and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) - An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy, Including Patients Who Failed Prior Treatment With Other TNF-Inhibitors (STEREO)
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies
- Conditions
- Psoriatic Arthritis
- Being tested
- adalimumab
- Keywords
- Psoriatic Arthritis, adalimumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters
PsARC
ACR20
Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
Patient reported outcomes
Secondary outcomes (1)
No differentiation will be made between primary and secondary efficacy variables.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 445 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beverly Paperiello, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235885
- Sponsor's protocol ID
- M04-724
- Other IDs
- EudraCT: 2005/001185-14
- Acronym
- STEREO
- Status last verified
- Aug 2007
- First submitted
- 7 Oct 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
Publications
Van den Bosch F, Kavanaugh A, Kron M, Kupper H, Mease PJ. Clinical remission in patients with active psoriatic arthritis treated with adalimumab and correlations in joint and skin manifestations. J Rheumatol. 2015 Jun;42(6):952-9. doi: 10.3899/jrheum.140312. Epub 2015 Apr 1.
PubMed 25834212Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.
PubMed 20553600
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) - An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy, Including Patients Who Failed Prior Treatment With Other TNF-Inhibitors (STEREO)
- ClinicalTrials.gov ID
- NCT00235885
- Acronym / sponsor ID
- STEREO / M04-724
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, adalimumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 12 Oct 2005 (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 the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females > 18 years of age
- Active PsA with > 3 tender and > 3 swollen joints despite standard therapy
- Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
- A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
- Use of a reliable method of contraception by all female patients of childbearing potential
Key exclusion criteria (15 listed)
- Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
- Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
- Treatment within last 4 weeks with a combination of MTX and leflunomide
- Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
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 |
|---|---|---|
| adalimumab | Drug | – |
Primary outcome
Safety parameters
PsARC
ACR20
Physician Global Assessment for Psoriasis and Psoriasis Target Lesion Assessment
Patient reported outcomes
1 secondary outcome
No differentiation will be made between primary and secondary efficacy variables.
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 29 Aug 2007.
- Derived from this study: PubMed 25834212Van den Bosch F, Kavanaugh A, Kron M, Kupper H, Mease PJ. Clinical remission in patients with active psoriatic arthritis treated with adalimumab and correlations in joint and skin manifestations. J Rheumatol. 2015 Jun;42(6):952-9. doi: 10.3899/jrheum.140312. Epub 2015 Apr 1.
- Derived from this study: PubMed 20553600Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.
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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.
Beverly Paperiello study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Psoriatic Arthritis, run by Abbott at 1 site 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 7 inclusion and 15 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 29 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Safety parameters. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00235885, which also lists 2 linked publications.
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 29 Aug 2007.