NCT00000401

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

6.1 years

First QC Date

November 3, 1999

Last Update Submit

May 28, 2013

Conditions

Rheumatoid Arthritis

Keywords

NSAIDsOral ToleranceDrug InteractionOral AdministrationInterleukin 10CollagenChemotherapyHuman Therapy EvaluationDMARDsRAIL-10

Outcome Measures

Primary Outcomes (1)

  • 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%.

    Before and after each 10-week treatment

Secondary Outcomes (1)

  • 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.

    Before and after each 10-week treatment

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

Oral bovine type II collagenDRUG

Drug can be interrupted or stopped for suspected adverse events.

Also known as: CII
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Arthritis Clinic of Jackson, PLLC

Jackson, Tennessee, 38301, United States

Location

University of Tennessee, Memphis

Memphis, Tennessee, 38163, United States

Location

Related Publications (2)

  • 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.

    PMID: 11177772BACKGROUND

  • 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.

    PMID: 15334493RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Arnold E. Postlethwaite, MD

    University of Tennessee at Memphis Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Expanded Access
Yes

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1999

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(2)