Trial Outcomes & Findings for PsA Treatment With hOKT3γ1 (Ala-Ala) (NCT NCT00239720)

Last Updated: 2017-04-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

6 Months

Results posted on

2017-04-27

Participant Flow

Two centers in the United States enrolled four participants between March 2006 and September 2006 who had psoriatic arthritis with three or more active joints despite ongoing therapy with methotrexate or azathioprine

At screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form

Participant milestones

Participant milestones
Measure	hOKT3gamma1 (Ala-Ala) Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle	Placebo Intravenous dose of placebo given over 5 days of each 28 day cycle
Overall Study STARTED	3	1
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	hOKT3gamma1 (Ala-Ala) Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle	Placebo Intravenous dose of placebo given over 5 days of each 28 day cycle
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

PsA Treatment With hOKT3γ1 (Ala-Ala)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	hOKT3gamma1 (Ala-Ala) n=3 Participants Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle	Placebo n=1 Participants Intravenous dose of placebo given over 5 days of each 28 day cycle	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.7 years STANDARD_DEVIATION 9.6 • n=5 Participants	54 years STANDARD_DEVIATION 0 • n=7 Participants	46.3 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Intent-to-treat

Outcome measures

Outcome data not reported

Adverse Events

hOKT3gamma1 (Ala-Ala)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	hOKT3gamma1 (Ala-Ala) n=3 participants at risk Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle	Placebo n=1 participants at risk Intravenous dose of placebo given over 5 days of each 28 day cycle
Immune system disorders Cytokine release syndrome	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)

Other adverse events

Additional Information

Marcus Clark, MD

University of Chicago

Phone: 773-702-0202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	hOKT3gamma1 (Ala-Ala) n=3 participants at risk Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle	Placebo n=1 participants at risk Intravenous dose of placebo given over 5 days of each 28 day cycle
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Chills	66.7% 2/3 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Epstein-Barr virus infection	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Hepatitis viral	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations CD4 lymphocytes decreased	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	100.0% 1/1 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	100.0% 1/1 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Headache	66.7% 2/3 • Number of events 6 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	100.0% 1/1 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	100.0% 1/1 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Dysuria	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Hyperhidrosis	66.7% 2/3 • Number of events 2 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Rash papular	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)	0.00% 0/1 • Baseline to end of study (up to 24 months post baseline visit) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)