Clinical Trials List
2014-03-14 - 2020-07-22
Phase IV
Terminated6
Study ended1
ICD-10M05.70
Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement
ICD-10M05.711
Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement
ICD-10M05.712
Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement
ICD-10M05.719
Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement
ICD-10M05.721
Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement
ICD-10M05.722
Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement
ICD-10M05.729
Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement
ICD-10M05.731
Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement
ICD-10M05.732
Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement
ICD-10M05.739
Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement
ICD-10M05.741
Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement
ICD-10M05.742
Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement
ICD-10M05.749
Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement
ICD-10M05.751
Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement
ICD-10M05.752
Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement
ICD-10M05.759
Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement
ICD-10M05.761
Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement
ICD-10M05.762
Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement
ICD-10M05.769
Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement
ICD-10M05.771
Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement
ICD-10M05.772
Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement
ICD-10M05.779
Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement
ICD-10M05.79
Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement
ICD-10M05.80
Other rheumatoid arthritis with rheumatoid factor of unspecified site
ICD-10M05.811
Other rheumatoid arthritis with rheumatoid factor of right shoulder
ICD-10M05.812
Other rheumatoid arthritis with rheumatoid factor of left shoulder
ICD-10M05.819
Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder
ICD-10M05.821
Other rheumatoid arthritis with rheumatoid factor of right elbow
ICD-10M05.822
Other rheumatoid arthritis with rheumatoid factor of left elbow
ICD-10M05.829
Other rheumatoid arthritis with rheumatoid factor of unspecified elbow
ICD-10M05.831
Other rheumatoid arthritis with rheumatoid factor of right wrist
ICD-10M05.832
Other rheumatoid arthritis with rheumatoid factor of left wrist
ICD-10M05.839
Other rheumatoid arthritis with rheumatoid factor of unspecified wrist
ICD-10M05.841
Other rheumatoid arthritis with rheumatoid factor of right hand
ICD-10M05.842
Other rheumatoid arthritis with rheumatoid factor of left hand
ICD-10M05.849
Other rheumatoid arthritis with rheumatoid factor of unspecified hand
ICD-10M05.851
Other rheumatoid arthritis with rheumatoid factor of right hip
ICD-10M05.852
Other rheumatoid arthritis with rheumatoid factor of left hip
ICD-10M05.859
Other rheumatoid arthritis with rheumatoid factor of unspecified hip
ICD-10M05.861
Other rheumatoid arthritis with rheumatoid factor of right knee
ICD-10M05.862
Other rheumatoid arthritis with rheumatoid factor of left knee
ICD-10M05.869
Other rheumatoid arthritis with rheumatoid factor of unspecified knee
ICD-10M05.871
Other rheumatoid arthritis with rheumatoid factor of right ankle and foot
ICD-10M05.872
Other rheumatoid arthritis with rheumatoid factor of left ankle and foot
ICD-10M05.879
Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot
ICD-10M05.89
Other rheumatoid arthritis with rheumatoid factor of multiple sites
ICD-10M05.9
Rheumatoid arthritis with rheumatoid factor, unspecified
ICD-10M06.00
Rheumatoid arthritis without rheumatoid factor, unspecified site
ICD-10M06.011
Rheumatoid arthritis without rheumatoid factor, right shoulder
ICD-10M06.012
Rheumatoid arthritis without rheumatoid factor, left shoulder
ICD-10M06.019
Rheumatoid arthritis without rheumatoid factor, unspecified shoulder
ICD-10M06.021
Rheumatoid arthritis without rheumatoid factor, right elbow
ICD-10M06.022
Rheumatoid arthritis without rheumatoid factor, left elbow
ICD-10M06.029
Rheumatoid arthritis without rheumatoid factor, unspecified elbow
ICD-10M06.031
Rheumatoid arthritis without rheumatoid factor, right wrist
ICD-10M06.032
Rheumatoid arthritis without rheumatoid factor, left wrist
ICD-10M06.039
Rheumatoid arthritis without rheumatoid factor, unspecified wrist
ICD-10M06.041
Rheumatoid arthritis without rheumatoid factor, right hand
ICD-10M06.042
Rheumatoid arthritis without rheumatoid factor, left hand
ICD-10M06.049
Rheumatoid arthritis without rheumatoid factor, unspecified hand
ICD-10M06.051
Rheumatoid arthritis without rheumatoid factor, right hip
ICD-10M06.052
Rheumatoid arthritis without rheumatoid factor, left hip
ICD-10M06.059
Rheumatoid arthritis without rheumatoid factor, unspecified hip
ICD-10M06.061
Rheumatoid arthritis without rheumatoid factor, right knee
ICD-10M06.062
Rheumatoid arthritis without rheumatoid factor, left knee
ICD-10M06.069
Rheumatoid arthritis without rheumatoid factor, unspecified knee
ICD-10M06.071
Rheumatoid arthritis without rheumatoid factor, right ankle and foot
ICD-10M06.072
Rheumatoid arthritis without rheumatoid factor, left ankle and foot
ICD-10M06.079
Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot
ICD-10M06.08
Rheumatoid arthritis without rheumatoid factor, vertebrae
ICD-10M06.09
Rheumatoid arthritis without rheumatoid factor, multiple sites
ICD-10M06.1
Adult-onset Still's disease
ICD-10M06.20
Rheumatoid bursitis, unspecified site
ICD-10M06.211
Rheumatoid bursitis, right shoulder
ICD-10M06.212
Rheumatoid bursitis, left shoulder
ICD-10M06.219
Rheumatoid bursitis, unspecified shoulder
ICD-10M06.221
Rheumatoid bursitis, right elbow
ICD-10M06.222
Rheumatoid bursitis, left elbow
ICD-10M06.229
Rheumatoid bursitis, unspecified elbow
ICD-10M06.231
Rheumatoid bursitis, right wrist
ICD-10M06.232
Rheumatoid bursitis, left wrist
ICD-10M06.239
Rheumatoid bursitis, unspecified wrist
ICD-10M06.241
Rheumatoid bursitis, right hand
ICD-10M06.242
Rheumatoid bursitis, left hand
ICD-10M06.249
Rheumatoid bursitis, unspecified hand
ICD-10M06.251
Rheumatoid bursitis, right hip
ICD-10M06.252
Rheumatoid bursitis, left hip
ICD-10M06.259
Rheumatoid bursitis, unspecified hip
ICD-10M06.261
Rheumatoid bursitis, right knee
ICD-10M06.262
Rheumatoid bursitis, left knee
ICD-10M06.269
Rheumatoid bursitis, unspecified knee
ICD-10M06.271
Rheumatoid bursitis, right ankle and foot
ICD-10M06.272
Rheumatoid bursitis, left ankle and foot
ICD-10M06.279
Rheumatoid bursitis, unspecified ankle and foot
ICD-10M06.28
Rheumatoid bursitis, vertebrae
ICD-10M06.29
Rheumatoid bursitis, multiple sites
ICD-10M06.30
Rheumatoid nodule, unspecified site
ICD-10M06.311
Rheumatoid nodule, right shoulder
ICD-10M06.312
Rheumatoid nodule, left shoulder
ICD-10M06.319
Rheumatoid nodule, unspecified shoulder
ICD-10M06.321
Rheumatoid nodule, right elbow
ICD-10M06.322
Rheumatoid nodule, left elbow
ICD-10M06.329
Rheumatoid nodule, unspecified elbow
ICD-10M06.331
Rheumatoid nodule, right wrist
ICD-10M06.332
Rheumatoid nodule, left wrist
ICD-10M06.339
Rheumatoid nodule, unspecified wrist
ICD-10M06.341
Rheumatoid nodule, right hand
ICD-10M06.342
Rheumatoid nodule, left hand
ICD-10M06.349
Rheumatoid nodule, unspecified hand
ICD-10M06.351
Rheumatoid nodule, right hip
ICD-10M06.352
Rheumatoid nodule, left hip
ICD-10M06.359
Rheumatoid nodule, unspecified hip
ICD-10M06.361
Rheumatoid nodule, right knee
ICD-10M06.362
Rheumatoid nodule, left knee
ICD-10M06.369
Rheumatoid nodule, unspecified knee
ICD-10M06.371
Rheumatoid nodule, right ankle and foot
ICD-10M06.372
Rheumatoid nodule, left ankle and foot
ICD-10M06.379
Rheumatoid nodule, unspecified ankle and foot
ICD-10M06.38
Rheumatoid nodule, vertebrae
ICD-10M06.39
Rheumatoid nodule, multiple sites
ICD-10M06.80
Other specified rheumatoid arthritis, unspecified site
ICD-10M06.811
Other specified rheumatoid arthritis, right shoulder
ICD-10M06.812
Other specified rheumatoid arthritis, left shoulder
ICD-10M06.819
Other specified rheumatoid arthritis, unspecified shoulder
ICD-10M06.821
Other specified rheumatoid arthritis, right elbow
ICD-10M06.822
Other specified rheumatoid arthritis, left elbow
ICD-10M06.829
Other specified rheumatoid arthritis, unspecified elbow
ICD-10M06.831
Other specified rheumatoid arthritis, right wrist
ICD-10M06.832
Other specified rheumatoid arthritis, left wrist
ICD-10M06.839
Other specified rheumatoid arthritis, unspecified wrist
ICD-10M06.841
Other specified rheumatoid arthritis, right hand
ICD-10M06.842
Other specified rheumatoid arthritis, left hand
ICD-10M06.849
Other specified rheumatoid arthritis, unspecified hand
ICD-10M06.851
Other specified rheumatoid arthritis, right hip
ICD-10M06.852
Other specified rheumatoid arthritis, left hip
ICD-10M06.859
Other specified rheumatoid arthritis, unspecified hip
ICD-10M06.861
Other specified rheumatoid arthritis, right knee
ICD-10M06.862
Other specified rheumatoid arthritis, left knee
ICD-10M06.869
Other specified rheumatoid arthritis, unspecified knee
ICD-10M06.871
Other specified rheumatoid arthritis, right ankle and foot
ICD-10M06.872
Other specified rheumatoid arthritis, left ankle and foot
ICD-10M06.879
Other specified rheumatoid arthritis, unspecified ankle and foot
ICD-10M06.88
Other specified rheumatoid arthritis, vertebrae
ICD-10M06.89
Other specified rheumatoid arthritis, multiple sites
ICD-10M06.9
Rheumatoid arthritis, unspecified
ICD-9714.0
Rheumatoid arthritis
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
-
Sponsor
Pfizer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/19
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 洪任諭 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Meng-Yu Weng Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱瑩明 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yao-Fan Fang Division of Rheumatology
- 郭宏輝 Division of Rheumatology
- 李荃 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳柏樟 風濕免疫科
- Po-Hao Huang 風濕免疫科
- Jiunn-Horng Chen 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- 黃建中 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
doses versus a TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular
events (MACE) and adjudicated malignancies excluding non-melanoma skin cancers during
study participation.
Inclution Criteria
of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Evidence of a personally signed and dated informed consent document indicating that the
subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Must be at least 50 years of age or older.
3. Has moderate to severe rheumatoid arthritis inadequately controlled with methotrexate
alone with a score of 6 or greater on the 2010 American College of
Rheumatology/European League Against Rheumatism Classification Criteria for
Rheumatoid Arthritis (Appendix 1)
4. Has ≥6 tender/painful joints on motion and ≥6 swollen joints (28 joint count)
5. Has a C-reactive protein measured by a high sensitivity assay (hs-CRP) ≥0.3 mg/dL in
the central laboratory
6. Meets Class I, II or III of the American College of Rheumatology (ACR) 1991 Revised
Criteria for Global Functional Status in RA where usual self-care activities including
dressing, feeding, bathing, grooming, and toileting; avocational (recreational and/or
leisure) and vocational (work, school, homemaking) activities are subject-desired and
age- and sex-specific.
Class I – Completely able to perform usual activities of daily living (self-care,
vocational, and avocational).
Class II – Able to perform usual self-care and vocational activities, but limited in
avocational activities.
Class III – Able to perform usual self-care activities, but limited in vocational and
avocational activities.
7. Has taken methotrexate continuously for at least 4 months prior to the Screening visit and
has taken a stable weekly dose of methotrexate with supplemental folic or folinic acid for
at least 6 weeks prior to the Baseline visit.
Methotrexate doses less than 15 mg/week are allowed only in the presence of
documented intolerance or toxicity from higher doses.
Doses higher than 25 mg/week are not permitted under any circumstances.
Folic acid doses should be at least 5 mg per week; folinic acid doses should be at least
2.5 mg per week.
8. Have at least one of the following cardiovascular risk factors at screening:
Current cigarette smoker
Diagnosis of hypertension
High density lipoprotein (HDL) <40 mg/dL
Diabetes mellitus
Family history of premature coronary heart disease (CHD); the family history should
be considered positive for premature CHD if clinical CHD or sudden death can be
documented in a first degree male relative younger than 55 years of age or in a first
degree female relative younger than 65 years of age
Presence of extra-articular disease associated with rheumatoid arthritis, which may
include nodules, Sjögren’s syndrome, anemia of chronic disease and pulmonary
manifestations
History of coronary artery disease including a history of revascularization procedure,
coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable
angina, acute coronary syndrome
9. Subjects must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
10. Male and female subjects of childbearing potential must agree to use a highly effective
method of contraception throughout the study and for at least 28 days after the last dose
of assigned treatment. A subject is of childbearing potential if, in the opinion of the
investigator, he/she is biologically capable of having children and is sexually active.
11. Female subjects of childbearing potential must test negative for pregnancy.
12. Female subjects who are not of childbearing potential must meet at least one of the
following criteria:
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure or;
Achieved postmenopausal status, defined as: cessation of regular menses for at least
12 consecutive months with no alternative pathological or physiological cause; and
have a serum follicle-stimulation hormone (FSH) level within the laboratory’s
reference range for postmenopausal females.
13. Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis
infection (active or latent) as evidenced by the following:
a. Negative QuantiFERON Gold®TM In-Tube test performed at screening
This is required unless the subject has been adequately treated for active or latent
tuberculosis or a negative QuantiFERON Gold®TM In-Tube test was previously
performed and documented within the 3 months prior to screening.
A negative tuberculin skin test (TST) is one that is <5 mm induration and it can
be substituted for the QuantiFERON Gold ® TM In-Tube test only if the central
laboratory is unable to perform the test or the test is reported as indeterminate
after at least 2 successive attempts.
It is strongly recommended that subjects with a history of Bacille Calmette Guérin
(BCG) vaccination be tested with the QuantiFERON Gold®™ In-Tube test.
b. Chest radiograph taken at screening without changes suggestive of active tuberculosis
(TB) infection, unless previously performed and documented within 3 months prior to
screening (see Section 7.3).
c. No history of tuberculosis infection unless one of the following is documented:
Subject with prior or current latent tuberculosis has no evidence of active
tuberculosis and must be taking or have completed an adequate course of therapy
for latent tuberculosis (9 months of isoniazid in a locale where rates of primary
multi-drug resistant TB infection are <5% or an alternative regimen recognized by
the World Health Organization) and a chest radiograph is negative for active
disease; the chest radiograph must be obtained at screening or, if previously
performed and documented, within 3 months prior to screening (see Section 7.3).
Subject with prior active tuberculosis has no current evidence of active disease
and has completed an adequate course of therapy for active tuberculosis (a multidrug regimen recognized by the World Health Organization) and a chest
radiograph is negative for active disease; the chest radiograph must be obtained at
screening or, if previously performed and documented, within 3 months prior to
screening (see Section 7.3).
Exclusion Criteria
for exclusion from the study will be documented:
1. Subjects who are investigational site staff members directly involved in the conduct of
the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of the
trial.
2. Subjects who are classified Class IV of the ACR 1991 Revised Criteria for Global
Functional Status in RA (ie, are limited in their ability to perform usual self-care,
vocational, and avocational activities).
3. Pregnant females; breastfeeding females; sexually active males and females of
childbearing potential who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at least 28
days after last dose of investigational product.
4. Subjects with infections or history of infections:
a. Any infection requiring treatment within 2 weeks prior to the Baseline visit.
b. Any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the past 6 months.
c. Infected joint prosthesis at any time with the prosthesis still in situ.
d. Recurrent (more than one episode) herpes zoster or disseminated (a single episode)
herpes zoster or disseminated (a single episode) herpes simplex.
e. Subjects will be screened for human immunodeficiency virus (HIV). Subjects who
test positive for HIV will be excluded from the study.
f. Subjects will be screened for hepatitis B virus infection. Subjects with hepatitis B
surface antigen (HBsAg) negative testing but who test positive for hepatitis B core
antibody (HBcAb) must have further testing for hepatitis B surface antibody
(HBsAb). If HBsAb is negative, the subject will be excluded from the study.
g. Subjects will be screened for hepatitis C virus antibodies (HCV Ab). Subjects with
positive HCV Ab tests will be reflex tested for hepatitis C virus ribonucleic acid
(HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to
enroll in the study.
h. Subjects are excluded for current active tuberculosis infection or prior active or latent
tuberculosis that was inadequately treated or cannot be documented (See Section 4.1
Inclusion Criteria #13).
5. Subjects with any current malignancy or a history of malignancy, with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.
6. Subjects with any uncontrolled clinically significant laboratory abnormality or any of the
following laboratory abnormalities:
a. Evidence of hematopoietic disorder or hemoglobin <9 g/dL
b. White blood cell count <3.0 x 109
/L (<3000/mm3
)
c. Absolute lymphocyte count <0.5 x 109
/L (<500/mm3
)
d. Absolute neutrophil count <1.0 x 109
/L (<1000/mm3
)
e. Platelet count <100 x 109
/L (<100,000/mm3
)
f. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times the
upper limit of normal (x ULN)
g. Estimated glomerular filtration rate (GFR) <60 mL/min using the Cockcroft-Gault
formula (Appendix 3).
7. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4
weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational
compound before the current study begins and/or during study participation, unless
further restrictions to class of compound are specified in Section 4.2 Exclusion Criteria
and Section 5.5 Concomitant Medication(s).
8. Subjects requiring or have received any prohibited concomitant medication as outlined in
Appendix 2, including:
a. Subjects who have received live or live attenuated vaccines within 6 weeks prior to
the first dose of study drug or at any time during treatment or within 6 weeks
following discontinuation of study drug (See Section 4.4.2).
b. Subjects who have been previously treated with tofacitinib.
c. Subjects who are being treated with biologic or non-biologic DMARDs other than
MTX or antimalarials within their specified washout window at study entry (see
Table 1).
d. Subjects who previously experienced inadequate response, intolerance, allergy or
hypersensitivity to adalimumab (US, Puerto Rico and Canada) or to etanercept (all
other countries) or for whom adalimumab (US, Puerto Rico and Canada) or
etanercept (all other countries) are contraindicated.
e. Subjects who are being treated with corticosteroids, other than low dose oral
corticosteroids in doses equivalent to 10 mg prednisone per day at study entry.
f. Subjects who require concomitant treatment with medications that are potent
inhibitors of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4
and potent inhibitors of CYP2C19, or potent CYP inducers.
9. Subjects who have Class III or Class IV heart failure according to the New York Heart
Association (NYHA) functional classification system.
10. Subjects with a screening 12-lead electrocardiogram that demonstrates clinically
significant abnormalities requiring urgent treatment (eg, acute myocardial infarction,
serious tachy- or bradyarrhythmias) or that is indicative of serious underlying heart
disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads).
11. Subjects who had significant trauma or surgical procedure within 1 month prior to the
Baseline visit.
12. Subjects with any rheumatic autoimmune disease, other than RA and Sjogren’s
syndrome.
13. Subjects with a first degree relative with a hereditary immunodeficiency.
14. Subjects with lymphoproliferative disorders (eg, Epstein Barr Virus (EBV) related
lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms
suggestive of current lymphatic disease.
15. Alcohol or substance abuse unless in full remission for greater than 6 months prior to first
dose of study drug.
16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
The Estimated Number of Participants
-
Taiwan
114 participants
-
Global
4000 participants
