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Trial Outcomes & Findings for Clinical Follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis (NCT NCT02958319)

NCT ID: NCT02958319

Last Updated: 2022-01-04

Results Overview

To explore the clinical differences in activity indexes (DAS28-ESR) at 6, 12 and 18 months of follow-up according the anti-CarP status. The DAS28 is a composite score derived from 4 measures, one of them can be the erythrocyte sedimentation rate (ESR). We will be using the DAS28-ESR version. To calculate the DAS28-ESR the rheumatologist or specialist nurse will:- count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure ESR, ask participants to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28-ESR is calculated with classic calculators and resulting values are interpreted as follows: \<2.6: disease remission 2.6 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity \>5.1: high disease activity

Recruitment status

COMPLETED

Target enrollment

278 participants

Primary outcome timeframe

6, 12 and 18 Months

Results posted on

2022-01-04

Participant Flow

278 patients were recruited in the study because they fullfilled the four follow-up visits in a retrospective/prospective manner after the informed consent signature and blood sample collection. After antibody analysis, 145 patients were found to be anti-CarP negative and 133 to be anti-CarP positive.

Participant milestones

Participant milestones
Measure
Anti P Carb Negative RA Patients
RA patients negative for antibodies against the carbamylated proteins
Anti P Carb Positive RA Patients
RA patients positive for antibodies against the carbamylated proteins
Overall Study
STARTED
145
133
Overall Study
COMPLETED
145
133
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Anti P Carb Negative RA Patients
n=145 Participants
RA patients negative for antibodies against the carbamylated proteins
Anti P Carb Positive RA Patients
n=133 Participants
RA patients positive for antibodies against the carbamylated proteins
Total
n=278 Participants
Total of all reporting groups
Age, Continuous
49.5 years
STANDARD_DEVIATION 11.4 • n=145 Participants
55.8 years
STANDARD_DEVIATION 10.64 • n=133 Participants
51.09 years
STANDARD_DEVIATION 11.13 • n=278 Participants
Sex: Female, Male
Female
135 Participants
n=145 Participants
119 Participants
n=133 Participants
254 Participants
n=278 Participants
Sex: Female, Male
Male
10 Participants
n=145 Participants
14 Participants
n=133 Participants
24 Participants
n=278 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Mexico
145 participants
n=145 Participants
133 participants
n=133 Participants
278 participants
n=278 Participants
SMOKE
55 Participants
n=145 Participants
59 Participants
n=133 Participants
114 Participants
n=278 Participants
DIABETES MELLITUS
17 Participants
n=145 Participants
21 Participants
n=133 Participants
38 Participants
n=278 Participants
CARDIOVASCULAR HISTORY
6 Participants
n=145 Participants
3 Participants
n=133 Participants
9 Participants
n=278 Participants
HYPERTENSION
27 Participants
n=145 Participants
26 Participants
n=133 Participants
53 Participants
n=278 Participants
HYPOTHYROIDSM
11 Participants
n=145 Participants
9 Participants
n=133 Participants
20 Participants
n=278 Participants
OSTHEOARTHRITIS
4 Participants
n=145 Participants
4 Participants
n=133 Participants
8 Participants
n=278 Participants
FIBROMYALGIA
3 Participants
n=145 Participants
1 Participants
n=133 Participants
4 Participants
n=278 Participants
DEPRESSION
2 Participants
n=145 Participants
2 Participants
n=133 Participants
4 Participants
n=278 Participants

PRIMARY outcome

Timeframe: 6, 12 and 18 Months

To explore the clinical differences in activity indexes (DAS28-ESR) at 6, 12 and 18 months of follow-up according the anti-CarP status. The DAS28 is a composite score derived from 4 measures, one of them can be the erythrocyte sedimentation rate (ESR). We will be using the DAS28-ESR version. To calculate the DAS28-ESR the rheumatologist or specialist nurse will:- count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure ESR, ask participants to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28-ESR is calculated with classic calculators and resulting values are interpreted as follows: \<2.6: disease remission 2.6 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity \>5.1: high disease activity

Outcome measures

Outcome measures
Measure
Anti P Carb Negative RA Patients
n=145 Participants
RA patients negative for antibodies against the carbamylated proteins
Anti P Carb Positive RA Patients
n=133 Participants
RA patients positive for antibodies against the carbamylated proteins
DAS28-ESR
6 MONTHS
3.75 units on a scale
Standard Deviation 1.31
3.72 units on a scale
Standard Deviation 1.3
DAS28-ESR
12 MONTHS
3.59 units on a scale
Standard Deviation 1.46
3.69 units on a scale
Standard Deviation 1.28
DAS28-ESR
18 MONTHS
3.65 units on a scale
Standard Deviation 1.35
3.77 units on a scale
Standard Deviation 1.32

Adverse Events

Anti P Carb Negative RA Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Anti P Carb Positive RA Patients

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

David Vega-Morales MD

Servicio de Reumatología del Hospital Universitario

Phone: 52 81 80485210

Results disclosure agreements

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