Psoriatic ArthritisPhase 2NCT00659412
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
A Phase 2 study testing Alefacept and Methotrexate in people with Psoriatic Arthritis, run by Astellas Pharma Inc at 27 sites in 5 countries.
Trial summary
Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Alefacept and Methotrexate
- 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
- 185 participants
- Where
- 27 sitesin 5 countries
- Study dates
- Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psoriatic arthritis
- MTX treatment for 3 months prior to enrollment with continuing disease
- Normal T-cell count
Who cannot join
- Other types of psoriasis
- History of malignancy or lymphoproliferative disorder
- Serious infection or fever
- Antibody positive for Hepatitis C, HIV or TB
- Hepatic transaminases > 2X normal
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
Canada7 sites
Study site
London, Ontario, N6A 4V2
Study site
Montreal, Quebec, H2L 1S6
Study site
Newmarket, Ontario, L3Y 3R7
Study site
St. John's, Newfoundland and Labrador, A1C 5B8
Study site
Toronto, Ontario, K1N 5N1
Study site
Toronto, Ontario, M5T 2S8
Study site
Victoria, British Columbia, V8V 3P9
Poland6 sites
Study site
Bialystok, 15-337
Study site
Elblag, 82-300
Study site
Kalisz, 62-800
Study site
Krakow, 30-119
Study site
Torun, 87-100
Study site
Warsaw, 02-637
Russia6 sites
Study site
Moscow, 107076
Study site
Moscow, 115522
Study site
Nizhny Novgorod, 603600
Study site
Saint Petersburg, 190068
Study site
Saint Petersburg, 194044
Study site
Yaroslavl, 150003
United States5 sites
Study site
Birmingham, Alabama, 35294
Study site
Lake Success, New York, 11042
Study site
Rochester, New York, 14642
Study site
Seattle, Washington, 98104
Study site
Wheaton, Maryland, 20902
Germany3 sites
Study site
Berlin, D-13125
Study site
Frankfurt, D-60590
Study site
Göttingen, D-37075
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course
Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.
Read the detailed description
Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.
- Conditions
- Psoriatic Arthritis
- Being tested
- Alefacept, Methotrexate, Placebo
- Keywords
- Psoriatic arthritis, psoriasis, Alefacept
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive, ASP0485
Intramuscular
MethotrexateDrug
Oral
PlaceboDrug
Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Course A1 | Experimental | Not described Receives: Drug: Alefacept; Drug: Methotrexate |
| Course A2 | Placebo comparator | Not described Receives: Drug: Methotrexate; Drug: Placebo |
| Course B | Experimental | Open-label extension Receives: Drug: Alefacept; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70
Measured: 12 Weeks and at any time
Secondary outcomes (3)
Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25
Measured: Each scheduled efficacy visit
Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear
Measured: Each scheduled efficacy visit
Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)
Measured: Baseline, 24 Weeks and 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startSep 2003
- Primary completionMar 2005
- Study completionMar 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659412
- Sponsor's protocol ID
- C-737
- Status last verified
- Sep 2014
- First submitted
- 14 Apr 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. doi: 10.1002/art.21870.
PubMed 16646026Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25.
PubMed 19028407
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course
- ClinicalTrials.gov ID
- NCT00659412
- Acronym / sponsor ID
- C-737
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic arthritis, psoriasis, Alefacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Sep 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 16 Apr 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.
Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.
Detailed description
Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Course A1 | Experimental | Drug: Alefacept, Drug: Methotrexate |
| Course A2 | Placebo comparator | Drug: Methotrexate, Drug: Placebo |
| Course B | Experimental | Drug: Alefacept, Drug: MethotrexateOpen-label extension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Psoriatic arthritis
- MTX treatment for 3 months prior to enrollment with continuing disease
- Normal T-cell count
Key exclusion criteria (5 listed)
- Other types of psoriasis
- History of malignancy or lymphoproliferative disorder
- Serious infection or fever
- Antibody positive for Hepatitis C, HIV or TB
- Hepatic transaminases > 2X normal
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 |
|---|---|---|
| AlefaceptAlso: Amevive, ASP0485Intramuscular | Drug | Course A1, Course B |
| MethotrexateOral | Drug | Course A1, Course A2, Course B |
| PlaceboIntramuscular | Drug | Course A2 |
Primary outcome
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70
Time frame: 12 Weeks and at any time
3 secondary outcomes
Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25
Time frame: Each scheduled efficacy visit
Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear
Time frame: Each scheduled efficacy visit
Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)
Time frame: Baseline, 24 Weeks and 48 Weeks
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 18 Sep 2014.
- Background: PubMed 16646026Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. doi: 10.1002/art.21870.
- Background: PubMed 19028407Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25.
Related trials for Psoriatic Arthritis
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Active, not recruitingPhase 3
A Long-term Extension Study of Ustekinumab in Pediatric Participants
Crohn Disease, Colitis, Ulcerative
RecruitingObservational study
A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting
Arthritis, Psoriatic
RecruitingPhase 3
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Crohns Disease, Colitis, Ulcerative
RecruitingObservational study
A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants
Arthritis, Psoriatic
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.
Use Central Contact study director
Astellas Pharma US, Inc.
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alefacept and Methotrexate in people with Psoriatic Arthritis, run by Astellas Pharma Inc at 27 sites in 5 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 3 inclusion and 5 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Canada, Poland, Russia, United States, Germany. 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 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?
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70 (time frame: 12 Weeks and at any time). 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 NCT00659412, 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 18 Sep 2014.