Oral Collagen for Rheumatoid Arthritis

May 28, 2013 updated by: University of Tennessee

Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. The study will evaluate the effects of using oral bovine CII on RA patients by assessing the levels of inflammation markers such as interferon gamma (IFN-gamma), interleukin-10 (IL-10), and transforming growth factor beta (TGF-beta). This study is a multicenter clinical trial to be conducted at the University of Tennessee, Memphis (the lead center) and the West Tennessee Medical Specialty Clinic (a collaborating site).

Patients enrolled will be allowed to continue a constant dose of disease-modifying anti-rheumatic drugs (DMARDs) and prednisone less than or equal to 7.5 mg/day. Patients will be randomly assigned to one of two groups. The low dose group will receive 30 mcg daily for 10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks; the high dose group will receive 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks. Blood will be collected at screening and at Weeks 10, 20, and 30. Blood will be analyzed for indicators of inflammation.

Note: this trial is no longer being conducted as an intervention trial. Accrual has been discontinued, although patients previously enrolled are still being followed.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • The Arthritis Clinic of Jackson, PLLC
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee, Memphis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Note: accrual into this trial has been discontinued, but patients previously enrolled are still being followed.

Inclusion Criteria:

  • Clinically stable RA and unlikely to require adjustment of doses of DMARDs, NSAIDs, prednisone, or anti-TNFα therapies for the treatment phase of the study
  • Meets American College of Rheumatology (ACR) 1988 revised criteria for RA
  • Onset of disease at age 16 or older
  • Onset of disease at least 3 months prior to enrollment
  • PBMC - IFNγ - α1(II)/PBS stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit
  • Agree to discontinue herbal remedies described in this protocol
  • Agree to use acceptable forms of contraception

Exclusion Criteria:

  • Participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry
  • Currently taking greater than 7.5 mg prednisone daily
  • Intra-articular corticosteroid injections within 30 days prior to study entry
  • Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
  • Pregnancy
  • Beef allergy
  • Use of fish oil within 4 weeks of study entry
  • Previous use of auranofin or cyclophosphamide (all other DMARDs are allowed)
  • Previous autologous or heterologous stem cell transplantation
  • Active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
  • Intolerance to citrus juices or colorless carbonated beverages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The low dose group will receive CII 30 mcg daily for 10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks.
Drug: Oral bovine type II collagen
Drug can be interrupted or stopped for suspected adverse events.
Other Names:
  • CII
Experimental: 2
The high dose group will receive CII 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks.
Drug: Oral bovine type II collagen
Drug can be interrupted or stopped for suspected adverse events.
Other Names:
  • CII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Repeated measures analysis of variance with contrasts to determine if the change in the PBMC-IFN gamma-alpha 1(II)/PBS stimulation index is significantly at the 0.05 level and/or greater than or equal to 30%.
Time Frame: Before and after each 10-week treatment
Before and after each 10-week treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
A Pearson correlation coefficient will be calculated for the change in the PBMC-INF gamma-alpha1(II)/PBS stimulation index and the change in the reactivity to RA CII epitope alpha 1 (II) CB11 for each dose.
Time Frame: Before and after each 10-week treatment
Before and after each 10-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Arnold E. Postlethwaite, MD, University of Tennessee at Memphis Department of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR045255 (U.S. NIH Grant/Contract)
  • NIAMS-037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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