Adults 18 to 99, 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.
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12Primary· Week 12
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Group
Value
95% CI
CE-224,535
33.96
Placebo
36.17
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8Secondary· Week 2, 4, 8
ACR20 response: compared to baseline, \>=20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Week 2
Group
Value
95% CI
CE-224,535
13.21
Placebo
25.53
Week 4
Group
Value
95% CI
CE-224,535
32.08
Placebo
38.30
Week 8
Group
Value
95% CI
CE-224,535
30.19
Placebo
29.79
Percentage of Participants With American College of Rheumatology 50% (ACR50) ResponseSecondary· Week 2, 4, 8, 12
ACR50 response: compared to baseline, \>=50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Week 2
Group
Value
95% CI
CE-224,535
5.66
Placebo
6.38
Week 4
Group
Value
95% CI
CE-224,535
7.55
Placebo
8.51
Week 8
Group
Value
95% CI
CE-224,535
13.21
Placebo
12.77
Week 12
Group
Value
95% CI
CE-224,535
11.32
Placebo
17.02
Percentage of Participants With American College of Rheumatology 70% (ACR70) ResponseSecondary· Week 2, 4, 8, 12
ACR70 response: compared to baseline, \>=70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Week 2
Group
Value
95% CI
CE-224,535
3.77
Placebo
0.00
Week 4
Group
Value
95% CI
CE-224,535
5.66
Placebo
4.26
Week 8
Group
Value
95% CI
CE-224,535
5.66
Placebo
0.00
Week 12
Group
Value
95% CI
CE-224,535
3.77
Placebo
0.00
Number of Tender/Painful and Swollen JointsSecondary· Baseline, Week 2, 4, 8, 12
Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Baseline: Tender joints
Group
Value
95% CI
CE-224,535
13.13
± 7.13
Placebo
14.45
± 7.03
Baseline: Swollen joints
Group
Value
95% CI
CE-224,535
11.68
± 6.30
Placebo
12.45
± 6.80
Week 2: Tender joints
Group
Value
95% CI
CE-224,535
10.33
± 7.19
Placebo
12.26
± 7.11
Week 2: Swollen joints
Group
Value
95% CI
CE-224,535
8.39
± 6.52
Placebo
9.43
± 6.45
Week 4: Tender joints
Group
Value
95% CI
CE-224,535
8.64
± 6.54
Placebo
10.54
± 7.70
Week 4: Swollen joints
Group
Value
95% CI
CE-224,535
7.47
± 6.57
Placebo
7.80
± 6.47
Week 8: Tender joints
Group
Value
95% CI
CE-224,535
8.33
± 7.35
Placebo
9.81
± 6.83
Week 8: Swollen joints
Group
Value
95% CI
CE-224,535
7.00
± 6.16
Placebo
7.57
± 6.15
Physician Global Assessment (PGA) of ArthritisSecondary· Baseline, Week 2, 4, 8, 12
Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
Baseline
Group
Value
95% CI
CE-224,535
53.74
± 23.82
Placebo
54.83
± 23.56
Week 2
Group
Value
95% CI
CE-224,535
48.04
± 25.78
Placebo
50.65
± 22.06
Week 4
Group
Value
95% CI
CE-224,535
42.15
± 22.77
Placebo
48.28
± 26.22
Week 8
Group
Value
95% CI
CE-224,535
41.59
± 24.87
Placebo
47.72
± 25.09
Week 12
Group
Value
95% CI
CE-224,535
40.02
± 25.87
Placebo
41.25
± 21.14
Patient's Global Assessment of ArthritisSecondary· Baseline, Week 2, 4, 8, 12
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
Baseline
Group
Value
95% CI
CE-224,535
56.91
± 18.80
Placebo
59.34
± 15.19
Week 2
Group
Value
95% CI
CE-224,535
50.43
± 22.24
Placebo
49.66
± 21.57
Week 4
Group
Value
95% CI
CE-224,535
42.94
± 20.70
Placebo
42.24
± 23.87
Week 8
Group
Value
95% CI
CE-224,535
43.00
± 23.27
Placebo
42.81
± 23.68
Week 12
Group
Value
95% CI
CE-224,535
40.57
± 23.26
Placebo
40.00
± 21.16
Patient's Global Assessment of Arthritic PainSecondary· Baseline, Week 2, 4, 8, 12
Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
Baseline
Group
Value
95% CI
CE-224,535
51.33
± 25.08
Placebo
60.13
± 20.96
Week 2
Group
Value
95% CI
CE-224,535
49.20
± 23.85
Placebo
51.51
± 24.38
Week 4
Group
Value
95% CI
CE-224,535
43.70
± 22.75
Placebo
48.43
± 27.20
Week 8
Group
Value
95% CI
CE-224,535
40.90
± 24.94
Placebo
48.79
± 24.19
Week 12
Group
Value
95% CI
CE-224,535
42.07
± 27.02
Placebo
43.13
± 23.47
Health Assessment Questionnaire-Disability Index (HAQ-DI) ScoreSecondary· Baseline, Week 2, 4, 8, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0= least difficulty and 3= extreme difficulty.
Baseline
Group
Value
95% CI
CE-224,535
1.26
± 0.68
Placebo
1.38
± 0.62
Week 2
Group
Value
95% CI
CE-224,535
1.15
± 0.69
Placebo
1.22
± 0.65
Week 4
Group
Value
95% CI
CE-224,535
1.06
± 0.75
Placebo
1.19
± 0.74
Week 8
Group
Value
95% CI
CE-224,535
1.00
± 0.75
Placebo
1.23
± 0.74
Week 12
Group
Value
95% CI
CE-224,535
0.97
± 0.78
Placebo
1.04
± 0.68
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])Secondary· Baseline, Week 2, 4, 8, 12
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Baseline: (n= 53, 47)
Group
Value
95% CI
CE-224,535
5.11
± 0.94
Placebo
5.22
± 0.95
Week 2
Group
Value
95% CI
CE-224,535
4.55
± 1.16
Placebo
4.84
± 1.12
Week 4
Group
Value
95% CI
CE-224,535
4.22
± 1.32
Placebo
4.48
± 1.37
Week 8
Group
Value
95% CI
CE-224,535
4.21
± 1.31
Placebo
4.47
± 1.23
Week 12
Group
Value
95% CI
CE-224,535
4.10
± 1.38
Placebo
4.28
± 1.22
C-Reactive Protein (CRP)Secondary· Baseline, Week 2, 4, 8, 12
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline
Group
Value
95% CI
CE-224,535
11.53
± 13.78
Placebo
9.22
± 9.91
Week 2
Group
Value
95% CI
CE-224,535
11.04
± 14.32
Placebo
9.23
± 11.19
Week 4
Group
Value
95% CI
CE-224,535
11.22
± 15.60
Placebo
8.97
± 9.29
Week 8
Group
Value
95% CI
CE-224,535
12.88
± 17.96
Placebo
10.38
± 12.53
Week 12
Group
Value
95% CI
CE-224,535
11.85
± 17.10
Placebo
9.26
± 10.78
Incidence of Withdrawal Due to Lack of EfficacySecondary· Week 2, 4, 8, 12, 14
Number of participants who withrew due to lack of efficacy were reported.
Week 2
Group
Value
95% CI
CE-224,535
0
Placebo
0
Week 4
Group
Value
95% CI
CE-224,535
0
Placebo
0
Week 8
Group
Value
95% CI
CE-224,535
0
Placebo
0
Week 12
Group
Value
95% CI
CE-224,535
0
Placebo
3
Week 14
Group
Value
95% CI
CE-224,535
0
Placebo
3
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CE-224,535
Serious: 2/53 (4%)
Deaths: —
Placebo
Serious: 1/47 (2%)
Deaths: —
Serious adverse events (7 terms)
Reaction
System
CE-224,535
Placebo
Back injury
Injury, poisoning and procedural complications
—
—
Capsular contracture associated with breast implant
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07176390 — A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
· Phase 2
· recruiting
NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
· recruiting
NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
· Phase 4
· recruiting
NCT06492200 — Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
· NA
· recruiting
NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
· recruiting
Other Pfizer trials
Trials by the same sponsor.
NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna®
· not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market
· not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 4 April 2022
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/NCT00628095.