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Rheumatoid ArthritisNCT02616328

A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 2 sites in Saudi Arabia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
8 participants
Where
2 sitesSaudi Arabia
Study dates
26 Jan 2017to 12 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with confirmed rheumatoid arthritis

Who may be able to join

  • Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months
  • Started on tocilizumab, with or without previous history of biological treatment

Who cannot join

  • Pregnant or lactating women
  • Treated with an investigational drug within 30 days prior to initiation of study drug
  • Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results

Trial locations and contacts

2 sites in 1 country.

Saudi Arabia2 sites

  • King Khaled Uni Hospital; Oncology

    Riyadh, 11472

  • King Fahad Medical City; Gastroentrology

    Riyadh, 11525

Other trials in Saudi Arabia

About this study

Official title: A Multicenter, Prospective, Observational, Non-Interventional Study Evaluating the Efficacy and Safety of Using Tocilizumab (TCZ) for Confirmed Rheumatoid Arthritis (RA) Patients In Clinical Practice

This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.

Being tested
No intervention
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention administered in this study

Study groups in NCT02616328
Study groupRoleWhat they receive
Participants with confirmed rheumatoid arthritisNot described
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24

    Measured: Week 24

  2. Number of Participants with Adverse Events

    Measured: Up to 30 months

Secondary outcomes (14)

  1. Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  2. Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  3. Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24

    Measured: Week 12 and Week 24

  4. Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  5. Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  6. Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  7. Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  8. Percentage of Participants with DAS28 < 2.6 at Week 12

    Measured: Week 12

  9. Mean Change in DAS28

    Measured: Baseline, Week 12, and Week 24

  10. Mean Change in CDAI

    Measured: Baseline, Week 12, and Week 24

  11. Mean Change in TJC

    Measured: Baseline and Week 24

  12. Mean Change in SJC

    Measured: Baseline and Week 24

  13. Mean Change in CRP

    Measured: Baseline and Week 24

  14. Mean Change in PGH

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study start26 Jan 2017
  3. Primary completion12 Dec 2017
  4. Study completion12 Dec 2017

Why it stopped: Planned recruitment target not reached

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616328
Sponsor's protocol ID
ML29936
Status last verified
Oct 2018
First submitted
25 Nov 2015
Last updated
18 Oct 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 2 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Planned recruitment target not reached). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.

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