PsoriasisPhase 3CHAMPIONNCT00235820
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing adalimumab and MTX in people with Psoriasis, run by Abbott at 1 site in United States.
Trial summary
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo 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 and MTX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 2006
- 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 was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- Male subjects must hve been vasectomized or practicing birth control.
Who cannot join
- Previous systemic anti-TNF therapy.
- Prior use of MTX.
- Known hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
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- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids during the study.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
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: A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Psoriasis
- Being tested
- adalimumab, MTX, placebo adalimumab, placebo MTX
- Keywords
- Psoriasis, 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
40 mg every other week following an 80 mg dose
MTXDrug
MTX 7.5 to 25 mg once weekly
placebo adalimumab, placebo MTXDrug
Also called placebo
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: adalimumab |
| B | Active comparator | Not described Receives: Drug: MTX |
| C | Placebo comparator | Not described Receives: Drug: placebo adalimumab, placebo MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Measured: Week 16
Safety parameters
Measured: Every Study Visit
Secondary outcomes (3)
Physician Global Assessment
Measured: Baseline - Week 16
PASI 50/90/100
Measured: Baseline - Week 16
DLQI
Measured: Baseline - Week 16
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
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235820
- Sponsor's protocol ID
- M04-716
- Acronym
- CHAMPION
- Status last verified
- Jun 2008
- First submitted
- 7 Oct 2005
- Last updated
- 17 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.
PubMed 26547918
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00235820
- Acronym / sponsor ID
- CHAMPION / M04-716
- Conditions
- Psoriasis
- Keywords
- Psoriasis, adalimumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- May 2006 (actual)
- 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.
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: adalimumab |
| B | Active comparator | Drug: MTX |
| C | Placebo comparator | Drug: placebo adalimumab, placebo MTX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- Male subjects must hve been vasectomized or practicing birth control.
Key exclusion criteria (10 listed)
- Previous systemic anti-TNF therapy.
- Prior use of MTX.
- Known hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
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 every other week following an 80 mg dose | Drug | A |
| MTXMTX 7.5 to 25 mg once weekly | Drug | B |
| placebo adalimumab, placebo MTXAlso: placeboplacebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX) | Drug | C |
Primary outcome
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Time frame: Week 16
Safety parameters
Time frame: Every Study Visit
3 secondary outcomes
Physician Global Assessment
Time frame: Baseline - Week 16
PASI 50/90/100
Time frame: Baseline - Week 16
DLQI
Time frame: Baseline - Week 16
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 17 Jul 2008.
- Derived from this study: PubMed 26547918Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.
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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.
Global Medical Information 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 and MTX in people with Psoriasis, 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 4 inclusion and 10 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 17 Jul 2008. 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. 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 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?
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. (time frame: Week 16). 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?
On the ClinicalTrials.gov record for NCT00235820, which also lists 1 linked publication.
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 17 Jul 2008.