PsoriasisPhase 2NCT00230529
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
A Phase 2 study testing infliximab in people with Psoriasis, run by Centocor, Inc..
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type 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?
- infliximab
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older at time of enrollment
- may be male or female
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
- Have plaque-type psoriasis covering at least 10% of total BSA at baseline
- Have previously received PUVA and/or other systemic treatment for psoriasis
Who cannot join
- Have non-plaque forms of psoriasis
- Have a history of drug-induced psoriasis
- Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
- Have had any previous treatment with infliximab or any therapeutic agent
About this study
Official title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients With Plaque-type Psoriasis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
Read the detailed description
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
- Conditions
- Psoriasis
- Being tested
- infliximab
- Keywords
- Plaque-type Psoriasis, infliximab, Remicade, biologics
- Medical subject headings
- Psoriasis
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 achieving a = 75% improvement in PASI score from baseline at week 10
Secondary outcomes (1)
The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study completionJan 2003
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 249 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
- NCT00230529
- Sponsor's protocol ID
- CR003124
- Status last verified
- Aug 2010
- First submitted
- 29 Sep 2005
- Last updated
- 9 Jun 2011
- Results posted
- No
Publications
Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021.
PubMed 15389187Feldman SR, Gordon KB, Bala M, Evans R, Li S, Dooley LT, Guzzo C, Patel K, Menter A, Gottlieb AB. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005 May;152(5):954-60. doi: 10.1111/j.1365-2133.2005.06510.x.
PubMed 15888152
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients With Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT00230529
- Acronym / sponsor ID
- CR003124
- Conditions
- Psoriasis
- Keywords
- Plaque-type Psoriasis, infliximab, Remicade, biologics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study completion
- Jan 2003 (actual)
- First posted
- 3 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.
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
Detailed description
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
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 (5 listed)
- Must be 18 years of age or older at time of enrollment
- may be male or female
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
- Have plaque-type psoriasis covering at least 10% of total BSA at baseline
- Have previously received PUVA and/or other systemic treatment for psoriasis
Key exclusion criteria (4 listed)
- Have non-plaque forms of psoriasis
- Have a history of drug-induced psoriasis
- Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
- Have had any previous treatment with infliximab or any therapeutic agent
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 achieving a = 75% improvement in PASI score from baseline at week 10
1 secondary outcome
The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26
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 9 Jun 2011.
- Results publication: PubMed 15389187Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021.
- Results publication: PubMed 15888152Feldman SR, Gordon KB, Bala M, Evans R, Li S, Dooley LT, Guzzo C, Patel K, Menter A, Gottlieb AB. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005 May;152(5):954-60. doi: 10.1111/j.1365-2133.2005.06510.x.
- A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients with Plaque-type Psoriasis.Link 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 2 study testing infliximab in people with Psoriasis, 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 5 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 9 Jun 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 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 = 75% improvement in PASI score 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 NCT00230529, 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 9 Jun 2011.