CompletedNCT01717859RASTSUpdated May 15, 2019Results posted

Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab

A Phase 4 interventional study of Tocilizumab in Rheumatoid Arthritis, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.

Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Other

Phase: Phase 4
Study type: Interventional
Enrollment: 74
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this research study is to determine if a change in inflammation or baseline inflammation seen on the ultrasound is a good indicator of how rheumatoid arthritis patients respond to TCZ 4mg/kg and whether early prediction of dose escalation is possible by utilizing ultrasound inflammatory measures.

Read the detailed description

This is a 24-week, double blind open label clinical trial study to evaluate 57 active Rheumatoid Arthritis (RA) patients who have moderate to severe disease activity with total Power Doppler Ultrasound (PDUS) >10 of 34 joints evaluated by Ultrasound (US) (at screening to enter into the study). All patients will begin treatment with tocilizumab at a dose of 4mg/kg. Two study sites will recruit patients (UCLA and UF) using the same protocol, after standardizing US acquisition methods, as well as scoring. US synovitis scores will be acquired at screening, baseline, and pre-infusion at 4, 12, 16, and 24 weeks, to be able to determine whether change in pre-infusion synovitis score at 4 weeks can be used to predict change in disease activity at 12 weeks. This will provide evidence to whether such reading is useful in predicting which patients may require escalation of dose from 4 to 8 mg/kg. At 12 weeks, patients not meeting low disease activity within the 4mg/kg (disease activity score DAS28/ Erythrocyte Sedimentation Rate (ESR)-4item\<3.2) will increase the tocilizumab dose to 8mg/kg (maximum dose 800mg) in a blinded manner to enable evaluation of these US-focused objectives in the context of the current FDA-approved label. The ultrasound scorer will not know information about patient's disease activity (Tender Joint Count (TJC), Swollen Joint Count (SJC), labs etc) or if there was dose escalation at 12 weeks. The clinical assessor of disease activity will be blinded to the ultrasound scores. Additionally, the patient will also be blinded to dose escalation. If patients in the 4mg/kg arm achieve DAS28\<3.2 at 12 weeks, patients will continue with their current dose for the duration of the study. Please see the below Table for details on the blinding plan.

Conditions studied

Rheumatoid Arthritis

Browse trials for

Keywords

Rheumatoid Arthritis

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 74 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria

Patients must have rheumatoid arthritis. Patients will be included in the trial based on the following criteria:

Patient must meet 1987 American College of Rheumatology (ACR) criteria,
Age > 18 years of age,
Baseline DAS28/ESR>4.4,
Stable concomitant DMARDs for more than 1 month (methotrexate, leflunomide, plaquenil, sulfasalazine, or no DMARDs). However, if the patient is not on DMARD, history of DMARD use required.
1. If not on DMARD (and the patient satisfies the above statement), the patient can opt for monotherapy with tocilizumab or combination therapy OR
2. If on biologic monotherapy, can opt for monotherapy with tocilizumab or DMARD combination therapy (ie. patients cannot be on biologic with TCZ)

Power Doppler score of >10 at screening.

General Medical Concerns:

Normal organ function, except if abnormal due to the disease under investigation
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
Subject has provided written informed consent.

Exclusion Criteria

A patient will be excluded if the answer to any of the following statements is "yes".

General:

Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 6 months after baseline.
Excluded Previous or Concomitant Therapy:
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of baseline.
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3.
Previous treatment with anti-CD19 and anti-CD20 within 6 months of start of the study.
Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
Previous treatment with TCZ.
Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
Use of prednisone > 10mg at baseline.
Exclusions for General Safety:
History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.)
Current liver disease as determined by principal investigator unless related to primary disease under investigation
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or oral antibiotics within 2 weeks prior to baseline.
Active Tuberculosis (TB) requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patients treated for tuberculosis with no recurrence in 3 years are permitted.
Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 5 years.
Pregnant women or nursing (breast feeding) mothers.
Patients with reproductive potential not willing to use an effective method of contraception.
History of alcohol, drug or chemical abuse within 1 year prior to screening.
Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.
Patients with lack of peripheral venous access.
Body weight of > 150 kg.
Laboratory Exclusion criteria (at screening):
Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL (168 µmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
Total Bilirubin > ULN
Platelet count \< 100 x 109/L (100,000/mm3)
Hemoglobin \< 85 g/L (8.5 g/dL; 5.3 mmol/L)
White Blood Cells \< 3.0 x 109/L (3000/mm3)
Absolute Neutrophil Count \< 2.0 x 109/L (2000/mm3)
Absolute Lymphocyte Count \< 0.5 x 109/L (500/mm3)
Positive Hepatitis BsAg, or Hepatitis C antibody
HIV positive

Study design

Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 74 participants (actual)

Study arms

Other
Tocilizumab
All subjects will receive tocilizumab.
Drug: Tocilizumab

Interventions

DrugTocilizumab
All subjects will start at 4mg/kg. After 3 months, if DAS28 \> 3.2, dosage will be escalated to 8 mg/kg.
Also known as: Actemra

What researchers measure

Primary outcomes

Baseline to Month 3 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)
34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Power Doppler scores. This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level.
Time frame: Baseline, 3 Month

Secondary outcomes

Baseline to Month 6 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)
34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Power Doppler scores. This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level.
Time frame: Baseline, 6 Month
Baseline to Month 3 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints
34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Synovial Hypertrophy Scores. This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level.
Time frame: Baseline, 3 Month
Baseline to Month 6 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints
34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Synovial Hypertrophy Scores. This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level.
Time frame: Baseline, 6 Month
Baseline to Month 3 Change in DAS28/ESR
28 joints will be evaluated for Tender Joint Count (TJC) and Swollen Joint Count (SJC) as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 3 Month Disease Activity Score (DAS) scores. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease.
Time frame: Baseline, 3 month
Baseline to Month 6 Change in DAS28/ESR
28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 6 Month DAS scores. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease.
Time frame: Baseline, 6 Month
Baseline to Month 3 Change in CDAI
28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 3 Month CDAI scores. The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity.
Time frame: Baseline, 3 month
Baseline to Month 6 Change in CDAI
28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 6 Month CDAI scores. The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity.
Time frame: Baseline, 6 Month

Results

Posted Nov 29, 2018

Participant flow

Patients were recruited through printed and internet advertisements, direct recruitment of study participants, referrals, review of medical records to identify potential participants, and through IRB approved screening protocol and IRB approved study. Patients were recruited starting on 9/24/14. The recruitment continued through November of 2016.

Participant flow — Overall Study
Milestone	Tocilizumab
Started	54
3 month	50
Completed	44
Not completed	10
Withdrew: Adverse event	5
Withdrew: Moved out of state	1
Withdrew: Patient concerned about mental health	1
Withdrew: Lost to follow-up	1
Withdrew: Withdrawal by subject	2

Outcome measures

PrimaryBaseline to Month 3 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)

34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Power Doppler scores. This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level.

Time frame:: Baseline, 3 Month
Reported as:: Mean · units on a scale

Baseline to Month 3 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)
units on a scale	Mean Change of Total Power Doppler Synovitis Score 3 Month
Baseline to Month 3 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)	6.84 ± 13.09

SecondaryBaseline to Month 6 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)

34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Power Doppler scores. This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level.

Time frame:: Baseline, 6 Month
Reported as:: Mean · units on a scale

Baseline to Month 6 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)
units on a scale	Mean Change of Total Power Doppler Synovitis Score 6 Month
Baseline to Month 6 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)	13.16 ± 15.68

SecondaryBaseline to Month 3 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints

34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Synovial Hypertrophy Scores. This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level.

Time frame:: Baseline, 3 Month
Reported as:: Mean · units on a scale

Baseline to Month 3 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints
units on a scale	Mean Change Total B-mode Synovial Hypertrophy Score 3 Month
Baseline to Month 3 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints	5.26 ± 12.55

SecondaryBaseline to Month 6 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints

34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Synovial Hypertrophy Scores. This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level.

Time frame:: Baseline, 6 Month
Reported as:: Mean · units on a scale

Baseline to Month 6 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints
units on a scale	Mean Change Total B-mode Synovial Hypertrophy Score 6 Month
Baseline to Month 6 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints	11.00 ± 15.32

SecondaryBaseline to Month 3 Change in DAS28/ESR

28 joints will be evaluated for Tender Joint Count (TJC) and Swollen Joint Count (SJC) as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 3 Month Disease Activity Score (DAS) scores. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease.

Time frame:: Baseline, 3 month
Reported as:: Mean · units on a scale

Baseline to Month 3 Change in DAS28/ESR
units on a scale	Mean Change in DAS28/ESR 3 Month
Baseline to Month 3 Change in DAS28/ESR	1.20 ± 1.08

SecondaryBaseline to Month 6 Change in DAS28/ESR

28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 6 Month DAS scores. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease.

Time frame:: Baseline, 6 Month
Reported as:: Mean · units on a scale

Baseline to Month 6 Change in DAS28/ESR
units on a scale	Mean Change in DAS28/ESR 6 Month
Baseline to Month 6 Change in DAS28/ESR	2.32 ± 1.22

SecondaryBaseline to Month 3 Change in CDAI

28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 3 Month CDAI scores. The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity.

Time frame:: Baseline, 3 month
Reported as:: Mean · units on a scale

Baseline to Month 3 Change in CDAI
units on a scale	Mean Change in CDAI 3 Month
Baseline to Month 3 Change in CDAI	9.64 ± 10.72

SecondaryBaseline to Month 6 Change in CDAI

28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 6 Month CDAI scores. The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity.

Time frame:: Baseline, 6 Month
Reported as:: Mean · units on a scale

Baseline to Month 6 Change in CDAI
units on a scale	Mean Change in CDAI 6 Month
Baseline to Month 6 Change in CDAI	16.70 ± 12.27

Adverse events

Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tocilizumab	0/54 (0%)	1/54 (1.9%)	51/54 (94.4%)

Most frequent serious events

Most frequent serious events
Event	Tocilizumab
Breast CancerReproductive system and breast disorders	1/54

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	Tocilizumab
Rheumatoid Arthritis FlareMusculoskeletal and connective tissue disorders	21/54
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders	21/54
HypercholesterolemiaCardiac disorders	17/54
LeukopeniaBlood and lymphatic system disorders	12/54
HeadachesGeneral disorders	10/54
HypokalemiaBlood and lymphatic system disorders	8/54
Bruises on Different Body SitesVascular disorders	6/54
DiarrheaGastrointestinal disorders	6/54
AnemiaBlood and lymphatic system disorders	5/54
Dry CoughRespiratory, thoracic and mediastinal disorders	5/54

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Tocilizumab
Mean	51.87 ± 15.16

Sex: Female, Male
Sex: Female, Male(Participants)	Tocilizumab
Female	49
Male	5

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Tocilizumab
American Indian or Alaska Native	1
Asian	4
Native Hawaiian or Other Pacific Islander	1
Black or African American	9
White	34
More than one race	0
Unknown or Not Reported	5

Region of Enrollment
Region of Enrollment(Participants)	Tocilizumab
United States	54

Disease duration
Disease duration(years)	Tocilizumab
Mean	9.94 ± 7.50

Disease Activity Score All Joints (DAS28)/ Erythrocyte Sedimentation Rate (ESR)
Disease Activity Score All Joints (DAS28)/ Erythrocyte Sedimentation Rate (ESR)(units on a scale)	Tocilizumab
Mean	6.30 ± 1.03

Clinical Disease Activity Index (CDAI)
Clinical Disease Activity Index (CDAI)(units on a scale)	Tocilizumab
Mean	39.04 ± 11.90

Health Assessment Questionnaire- Disability Index (HAQ-DI)
Health Assessment Questionnaire- Disability Index (HAQ-DI)(units on a scale)	Tocilizumab
Mean	1.47 ± 0.60

2 further baseline measures are reported on the registry.

Study locations

1 site

UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California 90095, United States

References and documents

Publications

Morris NT, Brook J, Ben-Artzi A, Martin W, Kermani TA, Avedikian-Tatosyan L, Karpouzas G, Nagam H, Navarro G, Choi S, Taylor MB, Elashoff D, Kaeley GS, Ranganath VK. Doppler ultrasound impacts response to intravenous tocilizumab in rheumatoid arthritis patients. Clin Rheumatol. 2021 Dec;40(12):5055-5065. doi: 10.1007/s10067-021-05857-7. Epub 2021 Jul 16. PubMed 34269927 ↗
Kuo D, Morris NT, Kaeley GS, Ben-Artzi A, Brook J, Elashoff DA, Ranganath VK. Sentinel joint scoring in rheumatoid arthritis: an individualized power Doppler assessment strategy. Clin Rheumatol. 2021 Mar;40(3):1077-1084. doi: 10.1007/s10067-020-05340-9. Epub 2020 Aug 15. PubMed 32803573 ↗
Choate EA, Kaeley GS, Brook J, Altman RD, FitzGerald JD, Floegel-Shetty AR, Elashoff DA, Ranganath VK. Ultrasound detects synovitis in replaced and other surgically operated joints in rheumatoid arthritis patients. BMC Rheumatol. 2020 Feb 3;4:8. doi: 10.1186/s41927-019-0107-2. eCollection 2020. PubMed 32025629 ↗

Study documents

Protocol and statistical analysis plan · Dec 5, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01717859
Lead sponsor: University of California, Los Angeles
Collaborators: Genentech, Inc.
Responsible party: Dr. Veena Ranganath (M.D., M.S., Assistant Clinical Professor, University of California, Los Angeles) — Principal investigator
First posted: Oct 31, 2012
Start date: Sep 2014
Primary completion: Apr 2017
Completion: Apr 2017
Results posted: Nov 29, 2018
Last update: May 15, 2019

Study contacts

Veena Ranganath, MD, MS

principal investigator · UCLA David Geffen School of Medicine, Division of Rheumatology

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

University of California, Los Angeles

Start the discussion