PsoriasisPhase 3NCT00679731
A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing ABT-874 and Methotrexate in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 43 sites in 14 countries.
Trial summary
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe 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?
- ABT-874 and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 43 sitesin 14 countries
- Study dates
- Apr 2008to Nov 2009
- 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
- Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above
Who cannot join
- Previous exposure to anti-IL 12
Trial locations and contacts
43 sites in 14 countries.
43 sites in 14 countries
Germany7 sites
Site Reference ID/Investigator# 8025
Berlin, 10117
Site Reference ID/Investigator# 8024
Frankfurt am Main, 60590
Site Reference ID/Investigator# 8032
Hamburg, D-20354
Site Reference ID/Investigator# 8027
Kiel, 24105
Site Reference ID/Investigator# 8035
Munich, D-80337
Site Reference ID/Investigator# 8019
Münster, 48149
Site Reference ID/Investigator# 8023
Tübingen, 72076
Canada5 sites
Site Reference ID/Investigator# 13104
Barrie, L4M 6L2
Site Reference ID/Investigator# 13161
Halifax, B3H 0A2
Site Reference ID/Investigator# 11864
Hamilton, L8N 1V6
Site Reference ID/Investigator# 13223
Québec, G1V 4X7
Site Reference ID/Investigator# 13221
Waterloo, N2J 1C4
Finland4 sites
Site Reference ID/Investigator# 8030
Helsinki, 00029 HUS
Site Reference ID/Investigator# 8033
Kuopio, 70211
Site Reference ID/Investigator# 8021
Lahti, 15850
Site Reference ID/Investigator# 8026
Turku, 20521
France4 sites
Site Reference ID/Investigator# 11661
Créteil, 94010
Site Reference ID/Investigator# 11504
Nice, 06200
Site Reference ID/Investigator# 11161
Paris, 75475
Site Reference ID/Investigator# 10963
Toulouse, 31059
Spain4 sites
Site Reference ID/Investigator# 13481
Barcelona, 08916
Site Reference ID/Investigator# 10702
Madrid, 28006
Site Reference ID/Investigator# 13163
Seville, 41009
Site Reference ID/Investigator# 8362
Valencia, 46014
Austria3 sites
Site Reference ID/Investigator# 9904
Graz, 8036
Site Reference ID/Investigator# 11001
Vienna, 1090
Site Reference ID/Investigator# 12763
Vienna, A-1030
Greece3 sites
Site Reference ID/Investigator# 13422
Athens, 161 21
Site Reference ID/Investigator# 13462
Athens, 16121
Site Reference ID/Investigator# 13461
Thessaloniki, 54643
Italy3 sites
Site Reference ID/Investigator# 12381
Milan, 20161
Site Reference ID/Investigator# 9583
Modena, 41100
Site Reference ID/Investigator# 8551
Rome, 00133
Denmark2 sites
Site Reference ID/Investigator# 11381
Aarhus, 8000
Site Reference ID/Investigator# 11841
Copenhagen NV, 2400
Netherlands2 sites
Site Reference ID/Investigator# 11701
Amsterdam, 1105 AZ
Site Reference ID/Investigator# 8363
Nijmegen, 6500 HB
Switzerland2 sites
Site Reference ID/Investigator# 10203
Geneva, 1211
Site Reference ID/Investigator# 8020
Zurich, 8091
United Kingdom2 sites
Site Reference ID/Investigator# 12401
Aberdeen, AB25 2ZR
Site Reference ID/Investigator# 8034
Manchester, M6 8HD
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
Read the detailed description
This study is only being conducted in the EU and Canada
- Conditions
- Psoriasis
- Being tested
- ABT-874, Methotrexate
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-874Drug
200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection
MethotrexateDrug
5.0 to 25 mg weekly
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ABT-874 Receives: Drug: ABT-874 |
| B | Active comparator | Methotrexate Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
Measured: Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24
Measured: Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52
Measured: Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52
Measured: Week 52
Secondary outcomes (4)
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24
Measured: Week 24
Changes from Baseline in the DLQI total score at Week 24
Measured: Week 24
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52
Measured: Week 52
Changes from Baseline in the DLQI total score at Week 52
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionNov 2009
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Kaul, MD, Study chair, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679731
- Sponsor's protocol ID
- M10-255
- Other IDs
- 2007-004687-47
- Status last verified
- Jan 2013
- First submitted
- 15 May 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243. No abstract available.
PubMed 22169986Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.
PubMed 22029980
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00679731
- Acronym / sponsor ID
- M10-255
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 May 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.
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
Detailed description
This study is only being conducted in the EU and Canada
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ABT-874ABT-874 |
| B | Active comparator | Drug: MethotrexateMethotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above
Key exclusion criteria (1 listed)
- Previous exposure to anti-IL 12
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 |
|---|---|---|
| ABT-874200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection | Drug | A |
| Methotrexate5.0 to 25 mg weekly | Drug | B |
Primary outcome
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
Time frame: Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24
Time frame: Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52
Time frame: Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52
Time frame: Week 52
4 secondary outcomes
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24
Time frame: Week 24
Changes from Baseline in the DLQI total score at Week 24
Time frame: Week 24
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52
Time frame: Week 52
Changes from Baseline in the DLQI total score at Week 52
Time frame: Week 52
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 Jan 2013.
- Derived from this study: PubMed 22169986Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243. No abstract available.
- Derived from this study: PubMed 22029980Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.
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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.
Martin Kaul, MD study chair
AbbVie
43 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABT-874 and Methotrexate in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 43 sites in 14 countries.
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 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany, Canada, Finland, France, Spain and 9 more countries. 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?
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 (time frame: Week 24). The study lists 4 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 NCT00679731, 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 Jan 2013.