Arthritis, PsoriaticPhase 3NCT00090129
Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Onercept in people with Arthritis, Psoriatic, run by EMD Serono at 40 sites in 2 countries.
Trial summary
The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Onercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 854 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Sep 2004to Jun 2005
- 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
- Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
- At least 18 years of age
- Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
- Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
- An out-patient status at the time of enrollment
Show all 10Show fewer
- Plaque psoriasis for at least 12 months
- Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
- Candidate for phototherapy or systemic therapy
- Static Physician's Global Assessment (sPGA) of 3 or more
Who cannot join
- Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
- Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
- Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
- Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
- Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
- Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
Show all 31Show fewer
- Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
- Phototherapy within 28 days before Study Day 1
- Use of tanning booths within 14 days before Study Day 1
- Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values
- Inadequate bone marrow reserve, defined as:
- Leukocytes less than or equal to 3.5 * 10^9 per liter (/L), or
- Thrombocytes less than or equal to 100 * 10^9 /L, or
- Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).
- Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.
- Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)
- Planned major surgery within the treatment period of the study.
- History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer
- History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis
- Active severe infection (or non-severe infection at the discretion of the Investigator).
- History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency
- Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)
- Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study
- History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse
- Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
- Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments
- Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigator's discretion)
- Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study
- Bedridden status
- Previous use of onercept
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States37 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Atlanta Dermatology Vein & Research Center
Alpharetta, Georgia, 30005
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
DermResearch Inc
Austin, Texas, 78759
Scott D. Glazer, MD
Buffalo Grove, Illinois, 60089
Midwest Cutaneous Research Corporation
Clinton Township, Michigan, 48038
Texas Dermatology Research Institute
Dallas, Texas, 75230
Colorado Medical Research Center
Denver, Colorado, 80210
Cherry Creek Research, Inc.
Denver, Colorado, 80246
Associates in Research Inc.
Fresno, California, 93710
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Center For Clinical Studies
Houston, Texas, 77030
University Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Center for Clinical Studies
Houston, Texas, 77058
University of California, Irvine
Irvine, California, 92697
North Florida Dermatology Associates, P.A.
Jacksonville, Florida, 32204
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Saint Mary's Centeral Wing Annex
Knoxville, Tennessee, 37917
Therapeutics Clinical Research
La Jolla, California, 92037
Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
Little Rock, Arkansas, 72205
Longmont Clinic PC
Longmont, Colorado, 80501
International Dermatology Research
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37221
The Savin Center P.C.
New Haven, Connecticut, 06511
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Northwest Cutaneous Research Specialist
Portland, Oregon, 97210
Oregon Medical Research Center, P.C.
Portland, Oregon, 97223
University of California
San Francisco, California, 94108
Clinical Research Specialists Inc.
Santa Monica, California, 90404
Dermatology Associates P.L.L.C.
Seattle, Washington, 98101
Rockwood Clinic, PS
Spokane, Washington, 99202
Solano Clinical Research
Vallejo, California, 94589
Dermatology Specialists Inc
Vista, California, 92083
Dermatology Associates, P.C. at the Washington Hospital CTR
Washington D.C., District of Columbia, 20010
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157
Canada3 sites
Probity Medical Research
Edmonton, Alberta, T5J3S9
Guenther Dermatology Research Center
London, Ontario, N6A 3H7
Probity Medical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis
The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Onercept, Placebo
- Keywords
- Psoriatic Arthritis, Moderate plaque psoriasis, severe plaque psoriasis, Onercept, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnerceptDrug
Also called recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)
Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
PlaceboDrug
Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Onercept | Experimental | Not described Receives: Drug: Onercept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Measured: Week 12
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Measured: Week 52
Secondary outcomes (10)
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Measured: Week 12
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Measured: Baseline up to Week 12
Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Measured: Baseline up to Week 12
Mean percentage improvement in the itching scale
Measured: Baseline up to Week 12
Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Measured: Baseline and Week 12
Median time to relapse
Measured: Week 12 up to Week 36
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Measured: Week 52
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Measured: Baseline up to Week 48
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Measured: Baseline up to Week 52
Mean Psoriatic Area and Severity Index (PASI) score
Measured: Week 36 up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startSep 2004
- Primary completionJun 2005
- Study completionJun 2005
Why it stopped: The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development
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 Arthritis, PsoriaticStudies 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, Investigator
- Enrolment
- 854 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090129
- Sponsor's protocol ID
- 24979
- Status last verified
- Oct 2013
- First submitted
- 24 Aug 2004
- Last updated
- 22 Oct 2013
- Results posted
- No
Publications
Papp K. Clinical development of onercept, a tumor necrosis factor binding protein, in psoriasis. Curr Med Res Opin. 2010 Oct;26(10):2287-300. doi: 10.1185/03007995.2010.507492.
PubMed 20718590
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00090129
- Acronym / sponsor ID
- 24979
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Moderate plaque psoriasis, severe plaque psoriasis, Onercept, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development
- Enrolment
- 854 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 26 Aug 2004 (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.
The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe 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 |
|---|---|---|
| Onercept | Experimental | Drug: Onercept |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
- At least 18 years of age
- Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- An out-patient status at the time of enrollment
- Plaque psoriasis for at least 12 months
Key exclusion criteria (31 listed)
- Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
- Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
- Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
- Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
- Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
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 |
|---|---|---|
| OnerceptAlso: recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment. | Drug | Onercept |
| PlaceboMatching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks. | Drug | Placebo |
Primary outcome
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Time frame: Week 12
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Time frame: Week 52
10 secondary outcomes
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Time frame: Week 12
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Time frame: Baseline up to Week 12
Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Time frame: Baseline up to Week 12
Mean percentage improvement in the itching scale
Time frame: Baseline up to Week 12
Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Time frame: Baseline and Week 12
Median time to relapse
Time frame: Week 12 up to Week 36
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Time frame: Week 52
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Time frame: Baseline up to Week 48
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Time frame: Baseline up to Week 52
Mean Psoriatic Area and Severity Index (PASI) score
Time frame: Week 36 up to Week 52
Results and safety
The study was stopped early (reason given: The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Results publication: PubMed 20718590Papp K. Clinical development of onercept, a tumor necrosis factor binding protein, in psoriasis. Curr Med Res Opin. 2010 Oct;26(10):2287-300. doi: 10.1185/03007995.2010.507492.
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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.
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Onercept in people with Arthritis, Psoriatic, run by EMD Serono at 40 sites in 2 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 10 inclusion and 31 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: stopped early, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. 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 was stopped early (reason given: The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development). Results are not available in the source record.
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?
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12 (time frame: Week 12). 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 NCT00090129, 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 22 Oct 2013.