Clinical Trials List
2012-12-01 - 2015-12-31
Phase III
Terminated3
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
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy
-
Trial Applicant
Johnson & Johnson
-
Sponsor
-
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
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 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Each joint is scored, according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating extensive loss of bone from more than one half of the articulating bone. Because each side of a foot joint is graded on this scale, the maximum erosion score for a foot joint is 10. Thus, the maximal erosion score is 280. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet.
Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or
complete luxation). Thus, the maximal JSN score is 168, giving 448 as the worst possible vdH-S score.
Inclution Criteria
1. Be a man or a woman of 18 years of age (or the legal age of consent in the jurisdiction
in which the study is taking place) or older.
2. Have a diagnosis of RA (according to the revised 1987 criteria of the ARA2) for at least 3 months before screening.
3. Have moderately to severely active RA with at least 6 of 68 tender joints and 6 of
66 swollen joints, at screening and at baseline.
4. Have been refractory to single-agent or combination DMARD therapy that includes
MTX or SSZ due to:
Lack of benefit after at least 12 weeks of DMARD, as assessed by the treating physician.
Documented lack of benefit may include inadequate improvement in joint counts,
physical function, or overall disease activity. It is recommended that subjects should have been exposed to the highest tolerated dose of MTX of up to 25 mg per week.
5. If using oral corticosteroids, must be on a stable dose equivalent to 10 mg/day of
prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent.
6. If using NSAIDs or other analgesics for RA, must be on a stable dose for at least
2 weeks prior to the first administration of study agent.
7. If using non-biologic DMARD such as MTX, SSZ, hydroxychloroquine (HCQ),
chloroquine (CQ), or bucillamine, must be on a stable dose for at least 4 weeks prior to
the first administration of study agent and should have no serious toxic side effects
attributable to the DMARD. If using MTX, the recommended doses are within the
range of 7.5 up to 25 mg PO or SC weekly, and treatment should have started at least 6
months prior to the first administration of study agent. If using SSZ, HCQ, CQ or
bucillamine, should have started treatment at least 3 months prior to the first
administration of study agent. If currently not using MTX, SSZ, HCQ, CQ, or bucillamine, must not have received these DMARDs for at least 4 weeks prior to the
first administration of the study agent.
8. CRP 8.00 mg/L at screening.
9. Subjects must meet 1 of the following 3 criteria prior to the first administration of study
agent: (a) anti-CCP antibody-positive at screening, (b) RF-positive at screening, or (c)
documented history of radiographic evidence of erosive RA in hands or feet prior to the
first administration of study agent.
10. Women, sexually active or otherwise capable of pregnancy, must practice a method of
birth control, including abstinence, intrauterine device, double barrier method (eg,
condoms, diaphragm, or cervical cap with spermicidal foam, cream or gel) or male
partner sterilization, consistent with local regulations regarding the use of birth control
methods for subjects participating in clinical trials. If using hormonal contraceptives,
including oral, injections and patches, a secondary method of contraception must be
used. Contraception must be used for the duration of their participation in the study,
and for 4 months after the last study agent administration.
11. Men, if sexually active with women of child bearing potential, are to use an effective
method of birth control and to not donate sperm during the study and for 4 months after
the last study agent administration.
12. Be willing and able to adhere to (a) the prohibitions and restrictions specified in this
protocol (b) the study visit schedule.
13. Be able to read, understand, and complete study questionnaires.
14. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
15. Subjects will be included according to the following TB screening criteria:
a. Have no history of latent or active TB prior to screening unless currently receiving
treatment for latent TB and there is no evidence of active TB. An exception is
made for subjects who have a history of latent TB (defined for the purposes of this
study as having had a positive result from either the tuberculin skin test
(Appendix B) or the QuantiFERON-TB Gold test (Appendix A) prior to
screening) and documentation of having completed an adequate treatment regimen
for latent TB within 3 years prior to the first administration of study agent under this protocol. Adequate treatment for latent TB is defined according to local
country guidelines for immunocompromised patients. If no local guidelines for
immunocompromised patients exist, US guidelines must be followed. It is the
responsibility of the investigator to verify the adequacy of previous anti-TB
treatment and provide appropriate documentation.
b. Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
c. Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent
TB prior to or simultaneously with the first administration of study agent.
d. Within 6 weeks of the first administration of study agent, have a negative
QuantiFERON-TB Gold test result or have a newly identified positive
QuantiFERON-TB Gold test result in which active TB has been ruled out and for
which appropriate treatment for latent TB has been initiated either prior to or
simultaneously with the first administration of study agent. A negative tuberculin
skin test or a newly identified positive tuberculin skin test result in which active
TB has been ruled out and for which appropriate treatment for latent TB has been
initiated either prior to or simultaneously with the first administration of study
agent is additionally required if the QuantiFERON-TB Gold test is not
approved/registered in that country.
e. Have a chest radiograph (both posterior-anterior (PA) and lateral view[s] unless
local guidelines recommend only a single view), taken within 3 months of the first
administration of study agent and read by a qualified pulmonologist or radiologist,
with no evidence of current, active TB or old, inactive TB.
16. Sign the informed consent form (ICF) for pharmacogenetics research indicating
willingness to participate in the pharmacogenetics component of the study (in order to
participate in the optional pharmacogenetics component of this study) where local
regulations permit. Refusal to give consent for this component does not exclude a
subject from participation in the clinical study
Exclusion Criteria
in the study. The subject will be excluded if he or she:
1. a. Has a history of intolerance to at least 2 or inadequate response to at least 1 antiTNF agent after 3 months of therapy.
b. Has received infliximab, golimumab, adalimumab, certolizumab pegol,
etanercept, or yisaipu within 3 months of the first study agent administration.
2. a. Has a history of intolerance to tocilizumab that precluded further treatment with it,
or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy.
b. Has used B-cell depleting therapy (eg, rituximab) within 7 months of first study
agent administration or have evidence during screening of abnormally low B cell
level caused by previous B-cell depletion therapy.
c. Has used anakinra within 4 weeks of first study agent administration.
d. Has used any other biologic therapy for the treatment of RA within 3 months of
the first study agent administration.
3. Has received intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA,
including adrenocorticotrophic hormone during the 4 weeks prior to first study agent
administration.
4. Has received leflunomide within 24 months before the first study agent administration
and have not undergone a drug elimination procedure, unless the M1 metabolite is
measured and is undetectable. Drug elimination procedure must be completed prior to
obtaining informed consent.
5. a. Has a history of cyclophosphamide or cytotoxic agent use.
b. Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil,
oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent
administration.
c. Has received an investigational drug (including investigational vaccines) or used
an investigational medical device within 3 months or 5 half lives, whichever is
longer, before the first study agent administration.
CNTO 136 (sirukumab) Clin
6. Has screening laboratory test result as follows:
a. Hemoglobin < 8.5 g/dL (International System of Units [SI]: < 85 g/L) or
< 5.3 mmol/L.
b. WBCs < 3.5 × 103
cells/μL (SI: < 3.5 × 109
cells/L).
c. Neutrophils < 1.95 × 103
cells/μL (SI: < 1.95 × 109
cells/L).
d. Platelets < 140 × 103
cells/μL (SI: < 140 × 109
cells/L).
e. Serum ALT or AST > 1.5 times the upper limit of normal (ULN) for the central
laboratory conducting the test.
f. Total bilirubin > ULN
g. Serum creatinine 2.0 mg/dL (SI: 177 μmol/L).
7. Has current signs or symptoms of severe, progressive, or uncontrolled active
inflammatory arthritis other than RA, renal, hepatic, dermatologic, hematologic,
gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease. Hospitalization
for a cardiovascular event (myocardial infarction, unstable angina, stroke, TIA within 3
months prior to the first administration of study agent is exclusionary.
8. Has known allergies, hypersensitivity, or intolerance to sirukumab or its excipients
(refer to sirukumab Investigator’s Brochure).
9. Has a history of severe allergic reaction to monoclonal antibodies or to murine,
chimeric, or human proteins or their excipients.
10. Has a marked baseline prolongation of the QTc interval ≥ 450 msec (either QTcB or
QTcF, machine or manual overread, males or females), a history of risk factors for
Torsade de Pointes such as persistent hypokalemia or family history of long QT
syndrome; or a history of second- or third-degree heart block.
11. Has had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or
pyelonephritis); or has been hospitalized for an infection; or has been treated with IV
antibiotics for an infection, within 2 months prior to the first administration of study
agent.
Has a history of chronic or recurrent infectious disease or ongoing infection including
but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract
infection (eg, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining
skin wound or an ulcer.
13. Has a chest radiograph within 3 months prior to the first administration of study agent
that shows an abnormality suggestive of a malignancy or current active infection,
including TB.
14. Has a history of known demyelinating diseases such as multiple sclerosis or optic
neuritis.
15. Has a history of gastrointestinal perforation or currently has active diverticulitis.
16. Has had a nontuberculous mycobacterial infection or opportunistic infection (eg,
cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
17. Is infected with HIV (positive serology for HIV antibody) or hepatitis C (positive
serology for Hep C antibody). If seropositive, consultation with a physician with
expertise in the treatment of HIV or hepatitis C virus infection is recommended.
18. Is infected with hepatitis B virus (Appendix C). For subjects who are not eligible for
this study due to HBV test results, consultation with a physician with expertise in the
treatment of hepatitis B virus infection is recommended.
19. Has any known malignancy or has a history of malignancy within the previous 5 years
(with the exception of a nonmelanoma skin cancer that has been treated with no
evidence of recurrence for at least 3 months before the first study agent administration
or cervical neoplasia that has been surgically cured).
20. Has uncontrolled psychiatric or emotional disorder, including a history of drug and
alcohol abuse within the past 3 years that might prevent the successful completion of the
study.
21. Has received, or is expected to receive, any live virus or bacterial vaccination within 3
months before the first administration of study agent, during the study, or within 4
months after the last administration of study agent.
Is pregnant or breast-feeding.
23. Has any condition that, in the opinion of the investigator, would make participation not
be in the best interest (eg, compromise the well-being) of the subject or that could
prevent, limit, or confound the protocol-specified assessments.
24. Is an employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well as
family members of the employees or the investigator.
The Estimated Number of Participants
-
Taiwan
27 participants
-
Global
1500 participants
