← Back to Search

Monoclonal Antibodies

CNTO 136 for Lupus

Verified Trial
Phase 1
Waitlist Available
Research Sponsored by Centocor Research & Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights

Study Summary

This trial studied the safety & PK of an IV drug in patients with lupus. It also assessed the drug's effects & response.

Eligible Conditions
  • Systemic Lupus Erythematosus
  • Cutaneous Lupus Erythematosus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Albumin and total protein
Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)
Bicarbonate
+19 more
Secondary outcome measures
British Isles Lupus Assessment Group (BILAG) score
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Immune response
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part B, 10 mg/kg CNTO 136/placeboExperimental Treatment2 Interventions
Group II: Part A, 4 mg/kg CNTO 136Experimental Treatment1 Intervention
Group III: Part A, 10 mg/kg CNTO 136Experimental Treatment1 Intervention
Group IV: Part A, 1 mg/kg CNTO 136Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Centocor Research & Development, Inc.Lead Sponsor
4 Previous Clinical Trials
2,088 Total Patients Enrolled
Centocor Research & Development, Inc., PA, USA Clinical TrialStudy DirectorCentocor Research & Development, Inc.
1 Previous Clinical Trials
46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept applicants who are octogenarians?

"This research project has a minimum age requirement of 18 and an upper bound for participation at 70 years old."

Answered by AI

Is this research endeavor accepting new participants?

"According to reports published on clinicaltrials.gov, this ongoing medical study was established in March 2007 and last modified in October 2012. It is currently recruiting participants for the trial."

Answered by AI

Is it feasible to become a participant in this research endeavor?

"Eligibility requirements for this research include a diagnosis of systemic lupus erythematosus and an age between 18-70. The total sample size is estimated to be 49 participants."

Answered by AI

Has the U.S. Food and Drug Administration granted approval for a 1 mg/kg dose of CNTO 136 in Part A?

"The safety of Part A, 1 mg/kg CNTO 136 was rated a 1 by our team at Power, as this is only Phase 1 trial with limited data regarding efficacy and safety."

Answered by AI

What is the most extensive number of individuals in this investigation?

"Indeed, the clinicaltrials.gov website shows that this research project is currently enrolling participants. It was first published on March 1st 2007 and last modified on October 5th 2012, with 49 volunteers being sought from a single medical site."

Answered by AI

What key outcomes are being measured in this research venture?

"The primary metric of this trial, which will be monitored for up to 26 weeks, is the frequency of adverse events. Additionally, the SELENA-SLEDAI Flare Composite (ranging from mild 0-105), pharmacodynamic evaluations involving serum and plasma biomarker data percentage changes since baseline measurements, and immune response in terms of antibodies formation are secondary objectives."

Answered by AI

Who else is applying?

What site did they apply to?
Skylight Health Research, Inc
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Most responsive sites:
  1. Skylight Health Research, Inc: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
2007. "A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01702740.
~4 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top