Clinical Trials List
2015-01-01 - 2017-09-30
Phase III
Terminated7
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
A Phase 3 Randomized, Double-Blind Study Assessing The Efficacy And Safety Of PF-06410293 And Adalimumab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
Pfizer, Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
ACR20 (20% or greater improvement as defined by the American College of Rheumatology)
at Week 12.
Secondary Endpoints
Safety measures characterized by type, incidence, severity, timing, seriousness and
relatedness of adverse events (AEs) and laboratory abnormalities.
Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab).
Categorical and continuous measures of clinical efficacy, including ACR20 (at time
points in addition to Week 12), ACR50, ACR70, change in DAS28-4 (CRP) (Disease
Activity Score-28; 4 components based on C-reactive protein), DAS28 remission (2.6),
EULAR (European League Against Rheumatism) response, ACR/EULAR remission, and
change from baseline in individual components of the ACR response.
Serum drug concentrations.
Exploratory Endpoint
PK/PD relationship for CRP in response to adalimumab-Pfizer and adalimumab-EU.
Inclution Criteria
Subject eligibility should be reviewed and documented by an appropriate member 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 legally acceptable representative) has been informed of all pertinent aspects
of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, lifestyle guidelines, and other study procedures.
3. Male and female subjects aged 18 years or older at the time of informed consent. Where
required by regulations, consent from a legally acceptable representative is required for
all subjects who are younger than 20 years of age.
4. Male and female subjects of childbearing potential and at risk for pregnancy must agree
to use a highly effective method of contraception throughout the study and for at least
6 months after the last dose of assigned treatment.
Female subjects of who are not of childbearing potential (ie, meet at least 1 of the
following criteria):
a. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; and have a serum follicle stimulating hormone (FSH) level
within the laboratory’s reference range for postmenopausal women; or
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; or
c. Have medically confirmed ovarian failure.
5. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of
Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification
criteria (see Appendix 1) for RA for at least a 4 month duration.
6. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in
RA (see Appendix 2).
7. Moderately to severely active RA disease as defined by the following criteria:
a. 6 tender joints (of 68 assessed) at both Screening and Baseline, and
b. 6 swollen joints (of 66 assessed) at both Screening and Baseline, and
c. Hs-CRP 8 mg/L (0.8 mg/dL) at Screening, performed by the central laboratory.
Subjects who do not meet this entry criteria but satisfy all other study entry
criteria may have serum hs-CRP concentration re-tested once within 14 days and,
if the repeat hs-CRP concentration is 8 mg/L (0.8 mg/dL), will be eligible to
enroll into the study provided all other inclusion/exclusion criteria are met.
8. Subjects must have received oral, subcutaneous (SC), or intramuscular (IM) methotrexate
for at least 12 weeks and been on a stable dosefor at least 4 weeks prior to first dose of
study drug. The stable dose must be 10 to 25 mg per week, with the exception of 6 to
25 mg per week where 6 mg per week is a recommended initial dose by local guidance or
standard of care.
9. Stable dose of oral folic acid (at least 1 mg/day on 5 days per week) or oral folinic acid
(5 mg once per week) supplementation for at least 21 days prior to the first dose of
study drug.
10. No current or prior treatment with adalimumab or lymphocyte depleting therapies
(eg, rituximab, Campath). Subjects may have received up to 2 doses of one biologic
therapy, including an anti-TNF inhibitor biologic agent (other than adalimumab),
enrolling after a washout period of at least 12 weeks or 5 half-lives prior to the first dose
of study drug, whichever is longer.
11. If receiving an oral corticosteroid, subject must be on a stable dose of 10 mg/day of
prednisone (or equivalent) for at least 4 weeks prior to the first dose of study drug.
Subject must not receive any IM or intra-articular (IA) corticosteroids within the 4 weeks
prior to the first dose of study drug.
12. If receiving an oral or topical non-steroidal anti-inflammatory drug
(NSAID)/Cox-2 inhibitor, subject must be on a stable dose of only one
NSAID/Cox-2 inhibitor drug for at least 4 weeks prior to the first dose of study drug at a
dosage less than or equal to the maximum recommended dose in the product information.
In addition, a cardiovascular dose of aspirin (325 mg/day) is permitted.
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
1. Pregnant females and breastfeeding females, male subjects with partners currently
pregnant, or male and female subjects 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 6 months after the last dose of study drug.
2. Clinically significant laboratory abnormalities at Screening, including but not limited to
inadequate bone marrow, liver, renal and immune system function as defined by the
following lab criteria:
a. Hemoglobin (Hgb) <9 g/dL.
b. Absolute neutrophil count (ANC) 1500 cells/mm3.
c. White blood cell (WBC) count <3.0 x 109/L.
d. Platelets <100 x 109/L.
e. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) 2 times the
upper limit of normal.
f. Bilirubin 1.5 times the upper limit of normal.
g. Serum creatinine 1.5 mg/dL.
Subjects who do not meet any lab entry criteria but satisfy all other study entry criteria
may have the lab re-tested within 14 days and, if within the required range, will be
eligible to enroll into the study provided all other inclusion/exclusion criteria are met.
3. Evidence or history of seizures, or nervous system demyelinating diseases (including
multiple sclerosis, optic neuritis, Guillain-Barré syndrome).
4. History of infection as evidenced by:
a. Infectious evidence or history of disseminated
Epstein Barr virus (EBV), human papilloma virus (HPV), or varicella zoster. A
single, limited episode in the past is not exclusionary.
b. Infection requiring hospitalization or parenteral antimicrobial therapy judged
clinically significant by the investigator within 6 months prior to first dose of
study drug.
c. History of an infected joint prosthesis at any time.
5. Known or Screen test positive for human immunodeficiency virus (HIV), hepatitis B
virus, or hepatitis C virus.
6. Evidence of untreated or inadequately treated latent, or inadequately treated active
infection with tuberculosis (TB) as defined by one or more of the following:
a. Positive TB test at Screening (QuantiFERON-TB Gold In-Tube Test).
b. Subjects previously treated for latent or active TB infection, or detected at
Screening, must have completed a successful course of treatment in accordance
with local guidelines. Subjects currently receiving TB therapy are excluded.
7. Chest radiography with evidence of active TB, fungal infections, or other clinically
significant abnormalities taken at Screening or within 12 weeks prior to Screening. If the
TB has been treated as specified in Exclusion Criteria 6b, the chest radiography TB result
will not exclude the subject.
8. Evidence of current or recent history of uncontrolled, clinically significant hematological,
renal, endocrine, pulmonary, gastrointestinal, hepatic, infectious, psychiatric, neurologic,
allergic, or cardiovascular disease including evidence or history of moderate or severe
heart failure (NYHA Class III/IV, see Appendix 9) or Screening 12-lead ECG that
demonstrates clinically relevant abnormalities which may affect subject safety, and
subjects who are contraindicated for treatment with adalimumab in accordance with the
approved local label.
9. Evidence or history of a malignancy within the past 5 years (with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin, or cervical carcinoma in situ with no evidence of recurrence), or history of any
lymphoproliferative disorder (eg, EBV related lymphoproliferative disorder, lymphoma,
or leukemia).
10. History of recurrent inflammatory joint disease other than RA (eg, post infectious
arthritis, gout, etc.) or history of any other autoimmune rheumatic diseases
(eg, vasculopathies, spondyloarthropathies, etc.) other than Sjogren’s syndrome.
11. Any current or prior treatment for the following DMARDs within the relevant washout
period (see Appendix 10):
a. Washout for 12 weeks prior to first dose of study drug with immunosuppressive
drugs, including alkylating agents (eg, cyclophosphamide and chlorambucil),
mycophenolate mofetil, leflunomide, azathioprine, or 6-mercaptopurine.
b. Washout for 8 weeks prior to first dose of study drug with gold therapy including
auranofin or injectable gold (aurothioglucose or aurothiomalate), tofacitinib,
tacrolimus, cyclosporine, and D-penicillamine.
c. Washout for 4 weeks prior to first dose of study drug for sulfasalazine or
anti-malarial drugs.
d. Washout for at least 4 weeks or 5 half-lives, whichever is longer, prior to first
dose of study drug for Investigational treatments for RA not specifically
mentioned.
12. Known requirement for treatment with prohibited concomitant medications during the
study.
13. Significant trauma or surgical procedure within 4 weeks prior to first dose of study drug.
14. Positive urine drug test at Screening for substances of abuse that is not due to prescribed
medication, or past or current history of addiction to or dependence on non-prescribed
substances within 12 months prior to Screening.
15. History of allergic or hypersensitivity reaction to active or inactive components of the
study drug.
16. Exposure to any live vaccines within 4 weeks prior to administration of the first dose of
study drug, or lack of willingness to avoid exposure to any live vaccines during the trial
and for at least 3 months after the last dose of study drug.
17. Participation in other studies involving investigational drug(s) (Phase 1-4) within at least
4 weeks or 5 half-lives of investigational product before the first dose of study drug
and/or during the study participation.
18. 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.
19. Subjects who are investigational site staff members directly involved in the conduct of
the study 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
study.
The Estimated Number of Participants
-
Taiwan
11 participants
-
Global
560 participants
