Trial Outcomes & Findings for Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients (NCT NCT01876329)

NCT ID: NCT01876329

Last Updated: 2015-05-29

Results Overview

Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.

• Recruitment status: COMPLETED
• Target enrollment: 125 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2015-05-29

Participant Flow

Participant milestones

Measure	Rheumatoid Arthritis Patients with seropositive or seronegative Rheumatoid Arthritis	Autoimmune Thyroid Disease (AITD) Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.	Control Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
Overall Study STARTED	45	36	44
Overall Study COMPLETED	45	36	44
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis n=45 Participants Patients with seropositive or seronegative Rheumatoid Arthritis	Autoimmune Thyroid Disease (AITD) n=36 Participants Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.	Control n=44 Participants Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses	Total n=125 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	25 Participants n=7 Participants	33 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 13.1 • n=5 Participants	55.1 years STANDARD_DEVIATION 17.2 • n=7 Participants	55.8 years STANDARD_DEVIATION 16.4 • n=5 Participants	56.8 years STANDARD_DEVIATION 15.6 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	28 Participants n=7 Participants	34 Participants n=5 Participants	95 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months

Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.

Outcome measures

Measure	Rheumatoid Arthritis n=45 Participants Patients with seropositive or seronegative Rheumatoid Arthritis	Autoimmune Thyroid Disease (AITD) n=36 Participants Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.	Control n=44 Participants Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
Prevalence of Vitamin B12 Deficiency	3 participants	6 participants	4 participants

SECONDARY outcome

Timeframe: 7 months

Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.

Outcome measures

Measure	Rheumatoid Arthritis n=45 Participants Patients with seropositive or seronegative Rheumatoid Arthritis	Autoimmune Thyroid Disease (AITD) n=36 Participants Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.	Control n=44 Participants Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
Presence of Anti-GPC Antibodies	7 participants	4 participants	8 participants

Adverse Events

Rheumatoid Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Autoimmune Thyroid Disease (AITD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew B. Carroll, MD

Keesler Medical Center

Phone: 228-376-3629

Email: matthew.carroll.1@us.af.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place