Completed

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

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What is being tested

Oral bovine type II collagen

+ Oral bovine type II collagen

Drug
Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 18 to 80 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1999
See protocol details

Summary

Principal SponsorUniversity of Tennessee
Last updated: May 29, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00000401
Principal SponsorUniversity of Tennessee
Last updated: May 29, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, Rheumatoid

Criteria

11 exclusion criteria prevent from participating
Active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
Beef allergy
Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
Currently taking greater than 7.5 mg prednisone daily
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

The Arthritis Clinic of Jackson, PLLC

Jackson, United StatesOpen The Arthritis Clinic of Jackson, PLLC in Google Maps

University of Tennessee, Memphis

Memphis, United States
Completed2 Study Centers