PsoriasisPhase 3NCT00106847
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis
A Phase 3 study testing Infliximab in people with Psoriasis and Parapsoriasis, run by Centocor, Inc..
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Parapsoriasis
- What is being tested?
- Infliximab
- How many people
- 683 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jul 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
- Patients with diagnosis of plaque-type psoriasis for at least 6 months
- Patients with plaque-type psoriasis covering at least 10% of the body
Who cannot join
- Patients with nonplaque forms of psoriasis
- Patients who have current drug-induced psoriasis
- Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
- Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
Read the detailed description
This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.
- Conditions
- Psoriasis, Parapsoriasis
- Being tested
- Infliximab
- Keywords
- plaque-type psoriasis, psoriasis, drug safety, drug efficacy, maintenance therapy, induction therapy, remicade
- Medical subject headings
- Psoriasis, Parapsoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.
Secondary outcomes (1)
Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physician's Global Assessment score of clear or excellent at week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2005 (estimated)
- Study startJan 2003
- Study completionJul 2005
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
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106847
- Sponsor's protocol ID
- CR005290
- Status last verified
- Apr 2010
- First submitted
- 31 Mar 2005
- Last updated
- 17 May 2011
- Results posted
- No
Publications
Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, Li S, Dooley LT, Arnold C, Gottlieb AB. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007 Jan;56(1):31.e1-15. doi: 10.1016/j.jaad.2006.07.017. Epub 2006 Sep 6.
PubMed 17097378
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT00106847
- Acronym / sponsor ID
- CR005290
- Conditions
- Psoriasis, Parapsoriasis
- Keywords
- plaque-type psoriasis, psoriasis, drug safety, drug efficacy, maintenance therapy, induction therapy, remicade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 1 Apr 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.
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
Detailed description
This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of plaque-type psoriasis for at least 6 months
- Patients with plaque-type psoriasis covering at least 10% of the body
Key exclusion criteria (4 listed)
- Patients with nonplaque forms of psoriasis
- Patients who have current drug-induced psoriasis
- Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
- Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor
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 |
|---|---|---|
| Infliximab | Drug | – |
Primary outcome
Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.
1 secondary outcome
Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physician's Global Assessment score of clear or excellent at week 10.
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 May 2011.
- Results publication: PubMed 17097378Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, Li S, Dooley LT, Arnold C, Gottlieb AB. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007 Jan;56(1):31.e1-15. doi: 10.1016/j.jaad.2006.07.017. Epub 2006 Sep 6.
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance Infliximab Therapy in Subjects with Plaque-type PsoriasisLink provided by the sponsor.
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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.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab in people with Psoriasis and Parapsoriasis, run by Centocor, Inc..
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 4 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 May 2011. 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. 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 patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.. 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 NCT00106847, 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 May 2011.