Rheumatoid ArthritisPhase 3NCT01256736
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 3 study testing Tocilizumab and DMARDs in people with Rheumatoid Arthritis, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab and DMARDs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Nov 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
- Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
- Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
- Willing to give written informed consent
Who cannot join
- History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
- ALT or AST > ULNⅹ2.5
- Platelet count < 100ⅹ103/ μL
- WBC < 3,000/mm3
- Absolute neutrophil count < 1,000/mm3
- Absolute lymphocyte count < 500/mm3
- Total bilirubin > ULNⅹ2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab, DMARDs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
DMARDsDrug
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab 8mg/kg + DMARDs | Experimental | Not described Receives: Drug: Tocilizumab; Drug: DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety results
- All AE/ADR during study
- Physical examination including vital signs and ECG
- Clinical laboratory results
Measured: 48weeks
Secondary outcomes (5)
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
Measured: 48weeks
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
Measured: 48weeks
Change of individual parameter in ACR core set
Measured: 48weeks
Change of individual parameter in DAS28
Measured: 48weeks
Change of individual parameter in Rheumatoid factor
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256736
- Sponsor's protocol ID
- CWP-TCZ302
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2010
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
PubMed 32508063
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
- ClinicalTrials.gov ID
- NCT01256736
- Acronym / sponsor ID
- CWP-TCZ302
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab 8mg/kg + DMARDs | Experimental | Drug: Tocilizumab, Drug: DMARDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
- Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
- Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
- Willing to give written informed consent
Key exclusion criteria (7 listed)
- History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
- ALT or AST > ULNⅹ2.5
- Platelet count < 100ⅹ103/ μL
- WBC < 3,000/mm3
- Absolute neutrophil count < 1,000/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumabintravenously at dose of 8mg/kg over 1 hour infusion every 4weeks | Drug | Tocilizumab 8mg/kg + DMARDs |
| DMARDsDMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide) | Drug | Tocilizumab 8mg/kg + DMARDs |
Primary outcome
Safety results
Time frame: 48weeks
1. All AE/ADR during study 2. Physical examination including vital signs and ECG 3. Clinical laboratory results
5 secondary outcomes
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
Time frame: 48weeks
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
Time frame: 48weeks
Change of individual parameter in ACR core set
Time frame: 48weeks
Change of individual parameter in DAS28
Time frame: 48weeks
Change of individual parameter in Rheumatoid factor
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Derived from this study: PubMed 32508063Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab and DMARDs in people with Rheumatoid Arthritis, run by JW Pharmaceutical at 1 site in South Korea.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety results (time frame: 48weeks). 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 NCT01256736, which also lists 1 linked publication.
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 20 Nov 2013.