Psoriatic ArthritisPhase 3NCT00195689
Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
A Phase 3 study testing Human anti-TNF monoclonal antibody/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 long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis 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?
- Human anti-TNF monoclonal antibody/adalimumab
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to 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
- Subject completed study M02-518 or M02-570
Who cannot join
- Subject prematurely discontinued study M02-518 or M02-570
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information-Abbott Laboratories
Abbott Park, Illinois, 60064
About this study
Official title: A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis
- Conditions
- Psoriatic Arthritis
- Being tested
- Human anti-TNF monoclonal antibody/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.
Human anti-TNF monoclonal antibody/adalimumabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements
Secondary outcomes (2)
Patient reported outcomes
Clinical response indicators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
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
- 400 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
- NCT00195689
- Sponsor's protocol ID
- M02-537
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.
PubMed 20537151Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.
PubMed 18684743
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
- A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00195689
- Acronym / sponsor ID
- M02-537
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- First posted
- 20 Sep 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 long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis
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 (1 listed)
- Subject completed study M02-518 or M02-570
Key exclusion criteria (3 listed)
- Subject prematurely discontinued study M02-518 or M02-570
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 |
|---|---|---|
| Human anti-TNF monoclonal antibody/adalimumab | Biological | – |
Primary outcome
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements
2 secondary outcomes
Patient reported outcomes
Clinical response indicators
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 20537151Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.
- Derived from this study: PubMed 18684743Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.
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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 Human anti-TNF monoclonal antibody/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 1 inclusion and 3 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 7 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 NCT00195689, 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.