Arthritis, PsoriaticPhase 2PARTNCT00239720
PsA Treatment With hOKT3γ1 (Ala-Ala)
A Phase 2 study testing hOKT3gamma1(Ala-Ala) in people with Arthritis, Psoriatic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine. 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?
- hOKT3gamma1(Ala-Ala)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Mar 2006to 25 Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 psoriatic arthritis. Participants do not need to have concurrent psoriasis to participate in the study;
- Active inflammation in 3 or more joints;
- Currently receiving ongoing therapy with methotrexate or azathioprine; and
- Willing to use acceptable forms of contraception.
Who cannot join
- Active infection with HIV, hepatitis C virus, or hepatitis B virus;
- Uncompensated heart failure or a recent myocardial infarction (heart attack) within the 6 months prior to study entry;
- Certain other serious illnesses or cancers;
- Participation in another clinical trial within the 6 weeks prior to study entry; or
- Pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado
Aurora, Colorado, 80010
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Treatment of Psoriatic Arthritis With hOKT3γ1 (Ala-Ala)
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.
Read the detailed description
Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the disease. In some severe cases of psoriatic arthritis, these drugs cannot adequately control the disease, often requiring patients to undergo continuous treatment to prevent or combat disease activity. hOKT3gamma1 (Ala-Ala) is a genetically engineered monoclonal antibody directed against the CD3 antigen on T cells. hOKT3gamma1 (Ala-Ala) specifically targets immune cells that are actively involved in destructive immune responses, such as those that cause psoriatic arthritis. In a small pilot study of eight people with psoriatic arthritis who received a 2-week course of hOKT3gamma1 (Ala-Ala), the drug appeared safe and caused no serious side effects. This study will test the safety and efficacy of hOKT3gamma1 (Ala-Ala) in alleviating symptoms in psoriatic arthritis patients.
This study will last 2 years. Individuals with psoriatic arthritis who are receiving methotrexate or azathioprine therapy and have active disease are eligible to participate. Participants will be randomly assigned to receive hOKT3gamma1 (Ala-Ala) or placebo. Participants will receive a 5-day treatment with the drug or placebo every month for the first 4 months of the study. There will be 5 study visits over 2 years to assess the safety and effectiveness of hOKT3gamma1 (Ala-Ala) and to evaluate laboratory measures related to the underlying immune problems that cause psoriatic arthritis.
- Conditions
- Arthritis, Psoriatic
- Being tested
- hOKT3gamma1(Ala-Ala), Placebo
- Keywords
- Psoriatic Arthritis, Arthritis, Psoriasis, Psoriatic, PsA
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hOKT3gamma1(Ala-Ala)Drug
Also called anti-CD3 monoclonal antibody
Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
PlaceboDrug
Also called Placebo comparator
Intravenous dose of placebo given over 5 days of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| hOKT3gamma1 (Ala-Ala) | Experimental | Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle Receives: Drug: hOKT3gamma1(Ala-Ala) |
| Placebo | Placebo comparator | Intravenous dose of placebo given over 5 days of each 28 day cycle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months
Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment
- The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].
- Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study start16 Mar 2006
- Primary completionDec 2006
- Study completion25 Jun 2008
Why it stopped: Study team decision-impact(s) of change in hOKT3γ1 (Ala-Ala) manufacturer during study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Marcus Clark, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239720
- Sponsor's protocol ID
- DAIT ITN011AI
- Acronym
- PART
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2005
- Last updated
- 27 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data access is provided in TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Psoriatic Arthritis With hOKT3γ1 (Ala-Ala)
- ClinicalTrials.gov ID
- NCT00239720
- Acronym / sponsor ID
- PART / DAIT ITN011AI
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Arthritis, Psoriasis, Psoriatic, PsA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team decision-impact(s) of change in hOKT3γ1 (Ala-Ala) manufacturer during study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- 16 Mar 2006 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- 25 Jun 2008 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 21 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.
Detailed description
Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the disease. In some severe cases of psoriatic arthritis, these drugs cannot adequately control the disease, often requiring patients to undergo continuous treatment to prevent or combat disease activity. hOKT3gamma1 (Ala-Ala) is a genetically engineered monoclonal antibody directed against the CD3 antigen on T cells. hOKT3gamma1 (Ala-Ala) specifically targets immune cells that are actively involved in destructive immune responses, such as those that cause psoriatic arthritis. In a small pilot study of eight people with psoriatic arthritis who received a 2-week course of hOKT3gamma1 (Ala-Ala), the drug appeared safe and caused no serious side effects. This study will test the safety and efficacy of hOKT3gamma1 (Ala-Ala) in alleviating symptoms in psoriatic arthritis patients.
This study will last 2 years. Individuals with psoriatic arthritis who are receiving methotrexate or azathioprine therapy and have active disease are eligible to participate. Participants will be randomly assigned to receive hOKT3gamma1 (Ala-Ala) or placebo. Participants will receive a 5-day treatment with the drug or placebo every month for the first 4 months of the study. There will be 5 study visits over 2 years to assess the safety and effectiveness of hOKT3gamma1 (Ala-Ala) and to evaluate laboratory measures related to the underlying immune problems that cause psoriatic arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hOKT3gamma1 (Ala-Ala) | Experimental | Drug: hOKT3gamma1(Ala-Ala)Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous dose of placebo given over 5 days of each 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of psoriatic arthritis. Participants do not need to have concurrent psoriasis to participate in the study;
- Active inflammation in 3 or more joints;
- Currently receiving ongoing therapy with methotrexate or azathioprine; and
- Willing to use acceptable forms of contraception.
Key exclusion criteria (5 listed)
- Active infection with HIV, hepatitis C virus, or hepatitis B virus;
- Uncompensated heart failure or a recent myocardial infarction (heart attack) within the 6 months prior to study entry;
- Certain other serious illnesses or cancers;
- Participation in another clinical trial within the 6 weeks prior to study entry; or
- Pregnant or breastfeeding.
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 |
|---|---|---|
| hOKT3gamma1(Ala-Ala)Also: anti-CD3 monoclonal antibodyEscalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle | Drug | hOKT3gamma1 (Ala-Ala) |
| PlaceboAlso: Placebo comparatorIntravenous dose of placebo given over 5 days of each 28 day cycle | Drug | Placebo |
Primary outcome
Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months
Time frame: 6 Months
Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment 1. The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2]. 2. Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Immune Tolerance Network (ITN) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data access is provided in TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.
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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.
Marcus Clark, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hOKT3gamma1(Ala-Ala) in people with Arthritis, Psoriatic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2017.