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Clinical Trials List

Protocol NumberCNTO136ARA3004

2014-05-01 - 2020-12-31

Phase III

Terminated4

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, Parallel-group Study of Long-term Safety and Efficacy of CNTO136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Johnson & Johnson

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator PING-NING HSU 風濕免疫科

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗 風濕免疫科

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chen Der-Yuan Division of Rheumatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Joung-Liang Lan 風濕免疫科

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Study ended

Condition/Disease

Rheumatoid Arthritis

Objectives

To evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNFα agents

Test Drug

CNTO136 (sirukumab)

Active Ingredient

sirukumab

Dosage Form

Pre-filled syringe

Dosage

50/100

Endpoints

The primary endpoint is the number of subjects with each of the following long-term safety
events through the end of the study: cardiovascular SAEs, malignancies, serious infections, and gastrointestinal perforations.

Inclution Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each
subject must:
1. Have completed the final study agent administrations in the primary study (Week 104
injection in CNTO136ARA3002 or Week 52 injection in CNTO136ARA3003) including all
other assessments required for these visits. The subject will then be deemed to have
completed participation in those studies and will be eligible to enroll in this long-term
extension study.
2. Sign an informed consent form (ICF) indicating that they understand the purpose of and
procedures required for the study and are willing to participate in the study.
3. Sign an informed consent form (ICF) for pharmacogenetics research 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
this clinical study.

Any potential subject who meets any of the following criteria will be excluded from participating
in the study. The subject will be excluded if he or she:
1. Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or
CNTO136ARA3003.
2. Is pregnant
3. Has active diverticulitis.
4. 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.

Exclusion Criteria

Any potential subject who meets any of the following criteria will be excluded from participating
in the study. The subject will be excluded if he or she:
1. Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or
CNTO136ARA3003.
2. Is pregnant
3. Has active diverticulitis.
4. 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.

The Estimated Number of Participants

  • Taiwan

    26 participants

  • Global

    2165 participants