Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01198509
First received: September 8, 2010
Last updated: December 31, 2014
Last verified: December 2014
Results First Received: September 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Periodontal Disease
Interventions: Drug: doxycycline
Drug: vancomycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment period: January 2010 - August 2012 Locations: Medical clinics and faculty practice offices

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable

Reporting Groups
  Description
Rheumatoid Arthritis (RA) - Doxycycline

Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.

doxycycline: doxycycline - 100 mg twice per day, for 2 months

N=5 (actual)

Rheumatoid Arthritis (RA) - Vancomycin

Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks

vancomycin: vancomycin, 250 mg four times a day, for 2 weeks

N=10 (actual)

Rheumatoid Arthritis (RA) Randomized to no Treatment

Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.

N=19 (actual)

Early RA Cross-sectional Cohort

Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).

N=66 (actual)

Psoriatic Arthritis (PsA)

Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.

N=20 (actual)

Healthy Volunteers

Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.

N=58 (actual)


Participant Flow:   Overall Study
    Rheumatoid Arthritis (RA) - Doxycycline     Rheumatoid Arthritis (RA) - Vancomycin     Rheumatoid Arthritis (RA) Randomized to no Treatment     Early RA Cross-sectional Cohort     Psoriatic Arthritis (PsA)     Healthy Volunteers  
STARTED     5     10     19     66     20     58  
COMPLETED     4 [1]   10     19     66     20     58  
NOT COMPLETED     1     0     0     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  
[1] Patient declined further participation after enrollment and allocation to treatment group



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rheumatoid Arthritis (RA) - Doxycycline

Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.

doxycycline: doxycycline - 100 mg twice per day, for 2 months

Rheumatoid Arthritis (RA) - Vancomycin

Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks

vancomycin: vancomycin, 250 mg four times a day, for 2 weeks

Rheumatoid Arthritis (RA) Randomized to no Treatment Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
Early RA Cross-sectional Cohort Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
Psoriatic Arthritis (PsA) Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
Healthy Volunteers Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
Total Total of all reporting groups

Baseline Measures
    Rheumatoid Arthritis (RA) - Doxycycline     Rheumatoid Arthritis (RA) - Vancomycin     Rheumatoid Arthritis (RA) Randomized to no Treatment     Early RA Cross-sectional Cohort     Psoriatic Arthritis (PsA)     Healthy Volunteers     Total  
Number of Participants  
[units: participants]
  5     10     19     66     20     58     178  
Age  
[units: years]
Mean (Full Range)
  44.0    (31 to 68)     41.5    (24 to 63)     39.2    (26 to 69)     49.1    (20 to 85)     45.5    (26 to 73)     40.7    (21 to 62)     44.2    (20 to 85)  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     4     10     18     58     19     58     167  
>=65 years     1     0     1     8     1     0     11  
Gender  
[units: participants]
             
Female     4     7     14     53     11     50     139  
Male     1     3     5     13     9     8     39  
Race (NIH/OMB)  
[units: participants]
             
American Indian or Alaska Native     0     0     0     0     0     0     0  
Asian     0     1     3     4     5     2     15  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0  
Black or African American     2     1     1     17     1     9     31  
White     1     2     1     16     6     12     38  
More than one race     2     6     14     29     8     35     94  
Unknown or Not Reported     0     0     0     0     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
             
Hispanic or Latino     3     7     15     41     8     43     117  
Not Hispanic or Latino     2     3     4     25     12     15     61  
Unknown or Not Reported     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     5     10     19     66     20     58     178  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alteration of Microbiota, Alteration of T Cell Function/Activation   [ Time Frame: 6 months ]

2.  Secondary:   Mean Units Change in DAS28 From Baseline to 6 Months   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Interpretation of results is limited by very small sample size. It should be noted that this was intended as a proof-of-concept study, and not a fully-powered clinical trial.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven B. Abramson, MD
Organization: New York University School of Medicine
phone: 212-263-8003
e-mail: StevenB.Abramson@nyumc.org


Publications of Results:
Other Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01198509     History of Changes
Other Study ID Numbers: 09-0658, RC2AR058986
Study First Received: September 8, 2010
Results First Received: September 3, 2014
Last Updated: December 31, 2014
Health Authority: United States: Institutional Review Board