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Oral Collagen for Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral bovine type II collagen
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring NSAIDs, Oral Tolerance, Drug Interaction, Oral Administration, Interleukin 10, Collagen, Chemotherapy, Human Therapy Evaluation, DMARDs, RA, IL-10

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Arthritis Clinic of Jackson, PLLC
  • University of Tennessee, Memphis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.

Full Information

First Posted
November 3, 1999
Last Updated
May 28, 2013
Sponsor
University of Tennessee
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000401
Brief Title
Oral Collagen for Rheumatoid Arthritis
Official Title
Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Tennessee
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
NSAIDs, Oral Tolerance, Drug Interaction, Oral Administration, Interleukin 10, Collagen, Chemotherapy, Human Therapy Evaluation, DMARDs, RA, IL-10

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral bovine type II collagen
Other Intervention Name(s)
CII
Intervention Description
Drug can be interrupted or stopped for suspected adverse events.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold E. Postlethwaite, MD
Organizational Affiliation
University of Tennessee at Memphis Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Arthritis Clinic of Jackson, PLLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
University of Tennessee, Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11177772
Citation
Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z.
Results Reference
background
PubMed Identifier
15334493
Citation
Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. doi: 10.1002/art.20361. No abstract available.
Results Reference
result

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Oral Collagen for Rheumatoid Arthritis

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