PsoriasisPhase 2NCT00645905
Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing adalimumab in people with Psoriasis, run by Abbott.
Trial summary
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Mar 2005
- 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
- Diagnosis of moderate to severe chronic plaque psoriasis
- Active psoriasis, despite topical therapies
Who cannot join
- Other active skin diseases or skin infections
- Prior exposure to any anti-TNF therapy
- Subject has other active skin diseases
- Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
- Poorly controlled medical conditions
- History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
Show all 11Show fewer
- History of cancer or lymphoproliferative disease
- History of active TB or listeriosis, or persistent chronic or active infections
- Known to have immune deficiency or is immunocompromised
- Clinically significant abnormal laboratory test results
- Erythrodermic psoriasis or generalized pustular psoriasis
About this study
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Psoriasis
- Being tested
- adalimumab, placebo for adalimumab
- Medical subject headings
- Psoriasis
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
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
placebo for adalimumabDrug
Also called placebo
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose
| 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.
Psoriasis Area and Severity Index
Measured: Week 12-Week 24
Adverse Events
Measured: Throughout Study Participation
Secondary outcomes (2)
Psoriasis Area and Severity Index
Measured: Week 12, Week 24 through 360 days after last dose
Physician's Global Assessment
Measured: Week 12, Week 24 through 360 days after last dose
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 startJun 2003
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645905
- Sponsor's protocol ID
- M02-538
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
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
- Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00645905
- Acronym / sponsor ID
- M02-538
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Mar 2005 (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.
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
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 (2 listed)
- Diagnosis of moderate to severe chronic plaque psoriasis
- Active psoriasis, despite topical therapies
Key exclusion criteria (11 listed)
- Other active skin diseases or skin infections
- Prior exposure to any anti-TNF therapy
- Subject has other active skin diseases
- Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
- Poorly controlled medical conditions
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, HumiraOL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose | Drug | A |
| placebo for adalimumabAlso: placeboOL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose | Drug | B |
Primary outcome
Psoriasis Area and Severity Index
Time frame: Week 12-Week 24
Adverse Events
Time frame: Throughout Study Participation
2 secondary outcomes
Psoriasis Area and Severity Index
Time frame: Week 12, Week 24 through 360 days after last dose
Physician's Global Assessment
Time frame: Week 12, Week 24 through 360 days after last dose
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.
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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 Psoriasis, 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 2 inclusion and 11 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?
Psoriasis Area and Severity Index (time frame: Week 12-Week 24). The study lists 2 primary outcomes in all. 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 28 Mar 2008.