Rheumatoid Arthritis (RA)Phase 3NCT01258712
Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
A Phase 3 study testing Tocilizumab + methotrexate(MTX) in people with Rheumatoid Arthritis (RA), run by Chugai Pharma Taiwan at 12 sites in Taiwan.
Trial summary
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Tocilizumab + methotrexate(MTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 12 sitesTaiwan
- Study dates
- Dec 2010to Oct 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
- Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
- Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.
Who cannot join
- Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
- Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
- Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
- Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
- Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand \& foot fungal infections can participate.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Taiwan12 sites
Buddhist Dalin Tzu Chi General Hospital
Chiayi City
Chang Gung Memorial Hospital -Kaohsiung
Kaohsiung City
Kaohsiung Medical University Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Cathay General Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital - Linkou
Taoyuan
About this study
Official title: Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Tocilizumab + methotrexate(MTX), Tocilizumab placebo + methotrexate(MTX)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab + methotrexate(MTX)Drug
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
Tocilizumab placebo + methotrexate(MTX)Drug
Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Tocilizumab + methotrexate(MTX) |
| 2 | Placebo comparator | Not described Receives: Drug: Tocilizumab placebo + methotrexate(MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an American College of Rheumatology 20(ACR20) response
Measured: at baseline and week 24
Secondary outcomes (12)
Proportion of patients with ACR50 response
Measured: at baseline and week 24
Proportion of patients with ACR70 response
Measured: at baseline and week 24
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Measured: at baseline and week 24
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Measured: at baseline and week 24
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Measured: at week 24
Adverse event incidence
Measured: from baseline to week 24
Mean change from baseline to evaluation visits in vital signs
Measured: from baseline to week 24
Result of Electrocardiogram. From baseline to evaluation visits
Measured: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
Measured: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).
Measured: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Measured: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharma Taiwan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshiaki Someya, Study chair, Chugai Pharma Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258712
- Sponsor's protocol ID
- MRA230TW
- Status last verified
- Dec 2012
- First submitted
- 8 Dec 2010
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01258712
- Acronym / sponsor ID
- MRA230TW
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chugai Pharma TaiwanIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 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.
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tocilizumab + methotrexate(MTX) |
| 2 | Placebo comparator | Drug: Tocilizumab placebo + methotrexate(MTX) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
- Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
- Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.
Key exclusion criteria (5 listed)
- Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
- Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
- Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
- Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
- Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand \& foot fungal infections can participate.
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 |
|---|---|---|
| Tocilizumab + methotrexate(MTX)Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week | Drug | 1 |
| Tocilizumab placebo + methotrexate(MTX)Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week | Drug | 2 |
Primary outcome
Proportion of patients with an American College of Rheumatology 20(ACR20) response
Time frame: at baseline and week 24
12 secondary outcomes
Proportion of patients with ACR50 response
Time frame: at baseline and week 24
Proportion of patients with ACR70 response
Time frame: at baseline and week 24
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Time frame: at baseline and week 24
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Time frame: at baseline and week 24
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Time frame: at week 24
Adverse event incidence
Time frame: from baseline to week 24
Mean change from baseline to evaluation visits in vital signs
Time frame: from baseline to week 24
Result of Electrocardiogram. From baseline to evaluation visits
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Time frame: from baseline to week 24
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 13 Dec 2012.
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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.
Yoshiaki Someya study chair
Chugai Pharma Taiwan
12 sites 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 + methotrexate(MTX) in people with Rheumatoid Arthritis (RA), run by Chugai Pharma Taiwan at 12 sites in Taiwan.
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 5 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 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients with an American College of Rheumatology 20(ACR20) response (time frame: at baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2012.