NCT00239720

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 16, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 21, 2012

Completed
Last Updated

April 27, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

October 13, 2005

Results QC Date

February 15, 2012

Last Update Submit

March 27, 2017

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic ArthritisArthritisPsoriasisPsoriaticPsA

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    6 Months

Study Arms (2)

hOKT3gamma1 (Ala-Ala)

EXPERIMENTAL

Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle

Drug: hOKT3gamma1(Ala-Ala)

Placebo

PLACEBO COMPARATOR

Intravenous dose of placebo given over 5 days of each 28 day cycle

Drug: Placebo

Interventions

hOKT3gamma1(Ala-Ala)DRUG

Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle

Also known as: anti-CD3 monoclonal antibody
hOKT3gamma1 (Ala-Ala)
PlaceboDRUG

Intravenous dose of placebo given over 5 days of each 28 day cycle

Also known as: Placebo comparator
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado

Aurora, Colorado, 80010, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticArthritisPsoriasis

Interventions

teplizumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

This study was put on voluntary clinical hold after a serious adverse event occurred. After a review of the data, the team decided to close the study to further enrollment. Due to limited participants, no formal statistical analyses were performed

Results Point of Contact

Title
Marcus Clark, MD
Organization
University of Chicago
mclark@medicine.bsd.uchicago.edu
773-702-0202

Study Officials

  • Marcus Clark, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

March 16, 2006

Primary Completion

December 1, 2006

Study Completion

June 25, 2008

Last Updated

April 27, 2017

Results First Posted

March 21, 2012

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Study overview, - synopsis, -navigator, -schedule of events, -available biospecimen(s) et al. (ITN011AI/NPA01 is Study ID)Access

Locations

US(2)