ArthritisPhase 2NCT00646386
Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
A Phase 2 study testing adalimumab in people with Arthritis and Psoriatic, run by Abbott.
Trial summary
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Apr 2004
- Phase
- Phase 2
- 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 PsA
- Inadequate response to DMARD therapy
- Corticosteroid stable dose <= 10 mg QD
- DMARDs must have been taken for 3 months and stable dose for 4 weeks
- MTX maximum dose = <= 30 mg/week
- Active chronic plaque PS or documented history of chronic plaque PS
Who cannot join
- No other active skin disease
About this study
Official title: Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis
- Being tested
- adalimumab, placebo for adalimumab
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
Also called ABT-D2E7, Humira
40 mg eow Week 0 - Week 24
placebo for adalimumabDrug
Also called placebo
40 mg eow Week 0 - Week 24
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: adalimumab |
| B | Placebo comparator | Not described Receives: Drug: placebo for adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20
Measured: Week 12
Adverse Events
Measured: Throughout study participation
Sharp Score
Measured: Week 24
Secondary outcomes (2)
ACR20, 50, 70
Measured: Weeks 12, 24
Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2003
- Primary completionApr 2004
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646386
- Sponsor's protocol ID
- M02-518
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
Publications
Landewe R, Ritchlin CT, Aletaha D, Zhang Y, Ganz F, Hojnik M, Coates LC. Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity. Rheumatology (Oxford). 2019 Jun 1;58(6):1025-1033. doi: 10.1093/rheumatology/key417.
PubMed 30608620Mease PJ, Heckaman M, Kary S, Kupper H. Application and modifications of minimal disease activity measures for patients with psoriatic arthritis treated with adalimumab: subanalyses of ADEPT. J Rheumatol. 2013 May;40(5):647-52. doi: 10.3899/jrheum.120970. Epub 2013 Mar 15.
PubMed 23504383
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00646386
- Acronym / sponsor ID
- M02-518
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Apr 2004 (actual)
- First posted
- 28 Mar 2008 (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.
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: adalimumab |
| B | Placebo comparator | Drug: placebo for adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate to severe PsA
- Inadequate response to DMARD therapy
- Corticosteroid stable dose <= 10 mg QD
- DMARDs must have been taken for 3 months and stable dose for 4 weeks
- MTX maximum dose = <= 30 mg/week
Key exclusion criteria (1 listed)
- No other active skin disease
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 |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira40 mg eow Week 0 - Week 24 | Drug | A |
| placebo for adalimumabAlso: placebo40 mg eow Week 0 - Week 24 | Drug | B |
Primary outcome
ACR20
Time frame: Week 12
Adverse Events
Time frame: Throughout study participation
Sharp Score
Time frame: Week 24
2 secondary outcomes
ACR20, 50, 70
Time frame: Weeks 12, 24
Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI
Time frame: Weeks 12 and 24
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 28 Mar 2008.
- Derived from this study: PubMed 30608620Landewe R, Ritchlin CT, Aletaha D, Zhang Y, Ganz F, Hojnik M, Coates LC. Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity. Rheumatology (Oxford). 2019 Jun 1;58(6):1025-1033. doi: 10.1093/rheumatology/key417.
- Derived from this study: PubMed 23504383Mease PJ, Heckaman M, Kary S, Kupper H. Application and modifications of minimal disease activity measures for patients with psoriatic arthritis treated with adalimumab: subanalyses of ADEPT. J Rheumatol. 2013 May;40(5):647-52. doi: 10.3899/jrheum.120970. Epub 2013 Mar 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adalimumab in people with Arthritis and Psoriatic, run by Abbott.
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 6 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 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
ACR20 (time frame: Week 12). The study lists 3 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 NCT00646386, 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 28 Mar 2008.