Sex: F
Vaccine: ANTH
Symptoms: Antinuclear antibody positive, Blood creatinine normal, Blood urea normal, Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: Rheumatoid arthritis;   Information was received on 05MAR2020 from an Investigator.   A 41-year-old female was diagnosed with rheumatoid arthritis (RA) approximately 1 month after the third dose of the blinded study drug.  Study drug administration dates: 10MAY2019: Dose 1 24MAY2019: Dose 2 07JUN2019: Dose 3  The subject received the first dose of study product on 10MAY2020 (Day 1).  Day 1 baseline labs revealed a positive antinuclear antibody (ANA) with a titer of 1:40 and a rheumatoid factor (RF) titer of 10 IU/mL (ref range is 0-14 IU/mL).  On 24MAY2019 (Day 15), the subject she was informed of her laboratory results in detail.  She agreed to continue with study treatment per protocol and received the second dose on the same day.  On 07JUN2019 (Day 29), though not part of routine testing, the PI requested a repeat ANA test considering the initial positive outcome.  The repeat test was positive at 1:40 (unchanged from the Day 1).  She was instructed to follow-up with rheumatology due to the positive results.  On the same day, she received her last dose of the study drug.   On 12JUL2019 (Day 64), an ANA test showed an increase to 1:80 with the RF titer remaining consistent with Day 1 labs (10 IU/ml).  She was informed of her result.  The subject stated she had visited a Rheumatologist, but she was unsure about her diagnosis. She was not taking any medication at that time.    The subject was requested to visit the site for the Day 302 visit.  During the visit, she informed the Sub-Investigator of a diagnosis of rheumatoid arthritis and was taking Sulfasalazine and Meloxicam.   Subsequently on 05MAR2020, repeat laboratory testing was performed.  Results are pending at the time of this report.  Medical records have been requested.   Outcome: The subject had not recovered at the time of report.   Concomitant therapy included Radiance (drospirenone/ethinyl estradiol) for birth control.    The action taken with study drug was not applicable as the rheumatoid arthritis was diagnosed after the last dose of study drug.   The Investigator assessed the event of grade 1 (mild) rheumatoid arthritis to be possibly related to therapy with study drug.  Medical Monitor assessed the event as unexpected and unrelated to the study products, based on the currently available information. The assessment may change if redacted medical records are received substantiating the diagnosis and it's justification. This event is unexpected and unrelated based on the fact that subject is said to be asymptomatic, and pre-vaccination & post-vaccination (Day 64) RF titers were 10 IU/mL and 10 IU/ml respectively within normal limits (0-14 IU/mL). BUN and creatinine were also within normal limits at Day 1 and 29. Though there was some increase in ANA titer from 1:40 to 1:80 from pre-vaccination to Day 64, this is not enough to substantiate this diagnosis of rheumatoid arthritis.  A preliminary assessment by a member of the safety board indicated the RF is normal, but the diagnosis of RA is also based upon cyclic citrullinated peptide (CCP) and proximal interphalangeal (PIP) joints on exam.  As a result, this assessment may change based on the results of anti- cyclic citrullinated peptide (anti-CCP) pre- and post-vaccination and redacted medical records  Company Comment: The Company assessed the event as not related to exposure with the blinded study product.  The assessment is based up the following:  there is no confirmed diagnosis, the subject is asymptomatic, ANA positive tests alone are not indicative alone, RF titer was negative, and lack of objective physical exam findings.  Medical records have been requested to confirm by objective evidence of additional testing/physical examination.; Sender's Comments: The Company assessed the event as not related to exposure with the blinded study product.  The assessment is based up the following:  there is no confirmed diagnosis, the subject is asymptomatic, ANA positive tests alone are not indicative alone, RF titer was negative, and lack of objective physical exam findings.  Medical records have been requested to confirm by objective evidence of additional testing/physical examination.