NCT03981900 is a clinical trial of Tofacitinib in Arthritis, Rheumatoid, sponsored by Pfizer.

Who is sponsoring NCT03981900?

NCT03981900 is sponsored by Pfizer.

What drugs are being tested in NCT03981900?

Interventions in NCT03981900: Tofacitinib, Tofacitinib.

What condition does NCT03981900 study?

NCT03981900 studies Arthritis, Rheumatoid.

Is NCT03981900 still recruiting?

NCT03981900 is currently completed. Last updated 1 October 2024.

Are results published for NCT03981900?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-01 · How we verify

NCT03981900

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

Completed Results posted Last updated 1 October 2024

What this trial tests

trial testing Tofacitinib in Arthritis, Rheumatoid in 314 participants. Completed in 6 February 2023.

Timeline

4 January 2019

Primary endpoint
6 February 2023

6 February 2023

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	314
Start date	4 January 2019
Primary completion	6 February 2023
Estimated completion	6 February 2023
Sites	66 locations across France

Drugs / interventions tested

Tofacitinib (tofacitinib) — full drug profile →
Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Tofacitinib Drug Survival Primary · Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)

The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.

Group	Value	95% CI
Tofacitinib	26.4	24.1 – NA

Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Secondary · Baseline, Month 1, 3, 6, 12, 18 and 24

PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \[4 items\], exaggeration \[3 items\] and helplessness \[6 items\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\>=) 20 indi

Baseline

Group	Value	95% CI
Tofacitinib	20.4	± 14.0

Change at Month 1

Group	Value	95% CI
Tofacitinib	-5.2	± 10.4

Change at Month 3

Group	Value	95% CI
Tofacitinib	-6.6	± 11.1

Change at Month 6

Group	Value	95% CI
Tofacitinib	-8.4	± 11.4

Change at Month 12

Group	Value	95% CI
Tofacitinib	-8.2	± 11.6

Change at Month 18

Group	Value	95% CI
Tofacitinib	-8.8	± 11.2

Change at Month 24

Group	Value	95% CI
Tofacitinib	-8.7	± 10.8

Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Secondary · Baseline, Month 1, 3, 6 12, 18 and 24

CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items,

Distraction at baseline

Group	Value	95% CI
Tofacitinib	13.2	± 3.8

Catastrophising at baseline

Group	Value	95% CI
Tofacitinib	8.4	± 3.0

Distancing from Pain at baseline

Group	Value	95% CI
Tofacitinib	7.3	± 3.2

Ignoring Pain Sensations at baseline

Group	Value	95% CI
Tofacitinib	11.3	± 3.6

Praying at baseline

Group	Value	95% CI
Tofacitinib	5.6	± 2.9

Distraction, Change at month 1

Group	Value	95% CI
Tofacitinib	-0.4	± 3.3

Catastrophising, Change at month 1

Group	Value	95% CI
Tofacitinib	-0.6	± 2.8

Distancing from Pain, Change at month 1

Group	Value	95% CI
Tofacitinib	-0.0	± 2.9

Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '4' in the name). Components includes: Tender Joint Count (TJC) with 28 joints assessed, Swollen Joint Count (SJC) with 28 joints assessed, ESR (millimeter per hours \[mm/h\]) and Patient Global Assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarit

Baseline

Group	Value	95% CI
Tofacitinib	7.2

Month 1

Group	Value	95% CI
Tofacitinib	34.9

Month 3

Group	Value	95% CI
Tofacitinib	46.4

Month 6

Group	Value	95% CI
Tofacitinib	52.4

Month 12

Group	Value	95% CI
Tofacitinib	57.0

Month 18

Group	Value	95% CI
Tofacitinib	55.2

Month 24

Group	Value	95% CI
Tofacitinib	60.2

Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \<=3.

Baseline

Group	Value	95% CI
Tofacitinib	9.8

Month 1

Group	Value	95% CI
Tofacitinib	46.2

Month 3

Group	Value	95% CI
Tofacitinib	55.9

Month 6

Group	Value	95% CI
Tofacitinib	69.3

Month 12

Group	Value	95% CI
Tofacitinib	66.0

Month 18

Group	Value	95% CI
Tofacitinib	71.9

Month 24

Group	Value	95% CI
Tofacitinib	73.7

Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + Physician Global Assessment (PhGA) (0-10 cm scale, higher score=more disease activity) + CRP (milligrams per deciliter \[mg/dL\]). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=11 indicates LDA. Percentage of participants with SDAI \<=11 is presented in this ou

Baseline

Group	Value	95% CI
Tofacitinib	6.6

Month 1

Group	Value	95% CI
Tofacitinib	39.4

Month 3

Group	Value	95% CI
Tofacitinib	54.0

Month 6

Group	Value	95% CI
Tofacitinib	67.2

Month 12

Group	Value	95% CI
Tofacitinib	64.7

Month 18

Group	Value	95% CI
Tofacitinib	68.2

Month 24

Group	Value	95% CI
Tofacitinib	74.1

Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=10 indicates LDA. Percentage of participants with CDAI \<=10 is presented in this outcome measure.

Baseline

Group	Value	95% CI
Tofacitinib	6.1

Month 1

Group	Value	95% CI
Tofacitinib	41.8

Month 3

Group	Value	95% CI
Tofacitinib	56.4

Month 6

Group	Value	95% CI
Tofacitinib	67.0

Month 12

Group	Value	95% CI
Tofacitinib	66.3

Month 18

Group	Value	95% CI
Tofacitinib	68.8

Month 24

Group	Value	95% CI
Tofacitinib	70.9

Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<2.6 indicat

Baseline

Group	Value	95% CI
Tofacitinib	3.6

Month 1

Group	Value	95% CI
Tofacitinib	17.8

Month 3

Group	Value	95% CI
Tofacitinib	27.6

Month 6

Group	Value	95% CI
Tofacitinib	34.9

Month 12

Group	Value	95% CI
Tofacitinib	32.6

Month 18

Group	Value	95% CI
Tofacitinib	33.6

Month 24

Group	Value	95% CI
Tofacitinib	38.8

Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

Baseline

Group	Value	95% CI
Tofacitinib	4.9

Month 1

Group	Value	95% CI
Tofacitinib	29.3

Month 3

Group	Value	95% CI
Tofacitinib	37.3

Month 6

Group	Value	95% CI
Tofacitinib	46.4

Month 12

Group	Value	95% CI
Tofacitinib	48.1

Month 18

Group	Value	95% CI
Tofacitinib	48.9

Month 24

Group	Value	95% CI
Tofacitinib	59.3

Percentage of Participants in Remission According to SDAI <=3.3 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity) + CRP (mg/dL). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=3.3 indicates LDA. Percentage of participants with SDAI \<=3.3 is presented in this outcome measure.

Baseline

Group	Value	95% CI
Tofacitinib	1.1

Month 1

Group	Value	95% CI
Tofacitinib	6.7

Month 3

Group	Value	95% CI
Tofacitinib	13.7

Month 6

Group	Value	95% CI
Tofacitinib	23.1

Month 12

Group	Value	95% CI
Tofacitinib	29.3

Month 18

Group	Value	95% CI
Tofacitinib	31.0

Month 24

Group	Value	95% CI
Tofacitinib	30.2

Percentage of Participants in Remission According to CDAI<=2.8 Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=2.8 indicates LDA. Percentage of participants with CDAI \<=2.8 is presented in this outcome measure.

Baseline

Group	Value	95% CI
Tofacitinib	0.7

Month 1

Group	Value	95% CI
Tofacitinib	6.7

Month 3

Group	Value	95% CI
Tofacitinib	14.8

Month 6

Group	Value	95% CI
Tofacitinib	21.5

Month 12

Group	Value	95% CI
Tofacitinib	26.5

Month 18

Group	Value	95% CI
Tofacitinib	26.2

Month 24

Group	Value	95% CI
Tofacitinib	29.9

Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Secondary · Baseline, Month 1, 3, 6, 12 18, and 24

ACREULAR 2011 Boolean criteria is derived as: ACR Remission = 1, if SJC (using 28 joints) \<=1, TJC (using 28 joints) \<=1, CRP \<=1 mg/dL, and PtGA (0 to 10 cm scale, higher score=more disease activity) \<=1 centimeter (cm) otherwise ACR remission =0. Higher scores indicated greater affection due to disease activity. Percentage of participants with remission according to ACR-EULAR 2011 Boolean criteria is reported in this outcome measure.

Baseline

Group	Value	95% CI
Tofacitinib	2.7

Month 1

Group	Value	95% CI
Tofacitinib	8.9

Month 3

Group	Value	95% CI
Tofacitinib	14.9

Month 6

Group	Value	95% CI
Tofacitinib	22.0

Month 12

Group	Value	95% CI
Tofacitinib	24.6

Month 18

Group	Value	95% CI
Tofacitinib	26.6

Month 24

Group	Value	95% CI
Tofacitinib	24.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tofacitinib

Serious: 64/309 (21%)

Deaths: 3/309

Serious adverse events (74 terms)

Reaction	System	Tofacitinib
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	—
COVID-19	Infections and infestations	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
APPENDICITIS	Infections and infestations	—
SHOULDER FRACTURE	Injury, poisoning and procedural complications	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	—
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
LYMPHOPROLIFERATIVE DISORDER	Blood and lymphatic system disorders	—
NEUTROPENIA	Blood and lymphatic system disorders	—
ACUTE CORONARY SYNDROME	Cardiac disorders	—
CARDIAC FAILURE	Cardiac disorders	—
CARDIAC TAMPONADE	Cardiac disorders	—
MYOCARDIAL INFARCTION	Cardiac disorders	—
PERICARDITIS	Cardiac disorders	—
OESOPHAGITIS	Gastrointestinal disorders	—
VOMITING	Gastrointestinal disorders	—
CHEST PAIN	General disorders	—
DEATH	General disorders	—
DRUG INEFFECTIVE	General disorders	—
DRUG THERAPEUTIC INCOMPATIBILITY	General disorders	—
INFLAMMATION	General disorders	—
MALAISE	General disorders	—
TREATMENT FAILURE	General disorders	—

Other adverse events (165 terms — click to expand)

Reaction	System	Tofacitinib
TREATMENT FAILURE	General disorders	—
BRONCHITIS	Infections and infestations	—
HEADACHE	Nervous system disorders	—
HERPES ZOSTER	Infections and infestations	—
DRUG INEFFECTIVE	General disorders	—
NAUSEA	Gastrointestinal disorders	—
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	—
URINARY TRACT INFECTION	Infections and infestations	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—
VOMITING	Gastrointestinal disorders	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	—
NASOPHARYNGITIS	Infections and infestations	—
RASH	Skin and subcutaneous tissue disorders	—
ASTHENIA	General disorders	—
FATIGUE	General disorders	—
INFLUENZA	Infections and infestations	—
SINUSITIS	Infections and infestations	—
WEIGHT INCREASED	Investigations	—
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	—
DIARRHOEA	Gastrointestinal disorders	—
LYMPHOPENIA	Blood and lymphatic system disorders	—
PALPITATIONS	Cardiac disorders	—
VERTIGO	Ear and labyrinth disorders	—
OEDEMA PERIPHERAL	General disorders	—
HEPATIC CYTOLYSIS	Hepatobiliary disorders	—
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	—
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	—
COUGH	Respiratory, thoracic and mediastinal disorders	—
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
NEUTROPENIA	Blood and lymphatic system disorders	—
CHEST DISCOMFORT	General disorders	—
CHEST PAIN	General disorders	—
TOOTH INFECTION	Infections and infestations	—
ARTHRITIS	Musculoskeletal and connective tissue disorders	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—
SCIATICA	Nervous system disorders	—
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: RHEUMATOID ARTHRITIS, COVID-19, BACK PAIN, APPENDICITIS, SHOULDER FRACTURE, ARTHRALGIA, TRANSIENT ISCHAEMIC ATTACK, LUNG DISORDER.

Data from ClinicalTrials.gov NCT03981900 adverse events section.

Sponsor's own description

Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available. Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA. As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03981900 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 1 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03981900.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03981900

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (74 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Tofacitinib

Other recruiting trials for Arthritis, Rheumatoid

Other Pfizer trials

Verify against primary sources