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Rheumatoid ArthritisPhase 3NCT01587989

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

A Phase 3 study testing methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 13 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to… 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?
methotrexate and tocilizumab [RoActemra/Actemra]
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
13 sitesAustria
Study dates
Feb 2012to Feb 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult patients, >/= 18 years of age
  • Rheumatoid arthritis of >/= 1 year duration
  • Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
  • On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
  • Body weight </= 150 kg
  • Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

Who cannot join

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Functional class IV American College of Rheumatology (ACR) Classification
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis
  • Treatment with a biologic agent at any time prior to baseline
  • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
Show all 15Show fewer
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with tocilizumab
  • Pregnant or lactating women
  • Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • History of or currently active primary or secondary immunodeficiency
  • Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV infection

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Austria13 sites

  • Study site

    Graz, 8036

  • Study site

    Graz-Eggenberg, 8020

  • Study site

    Hollabrunn, 2020

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Stockerau, 2000

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1140

  • Study site

    Vienna, 1160

  • Study site

    Wels, 4600

Other trials in Austria

About this study

Official title: A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Being tested
methotrexate, placebo, tocilizumab [RoActemra/Actemra]
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • methotrexateDrug

    15-25 mg orally weekly, Weeks 1-12

  • methotrexateDrug

    15-25 mg orally weekly, Weeks 13-24

  • placeboDrug

    methotrexate placebo orally weekly, Weeks 13-24

  • tocilizumab [RoActemra/Actemra]Drug

    8 mg/kg iv every 4 weeks, 24 weeks

Study groups in NCT01587989
Study groupRoleWhat they receive
A MethotrexateActive comparatorNot described
Receives: Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra]
B Methotrexate PlaceboExperimentalNot described
Receives: Drug: methotrexate; Drug: placebo; Drug: tocilizumab [RoActemra/Actemra]

What is being measured

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

  1. Change From Week 12 (Randomization) to Week 24 in DAS28

    The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.

    Measured: Weeks 12 and 24

Secondary outcomes (8)

  1. Percentage of Participants With DAS28 Remission at Week 24

    The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS. DAS28 < 2.6 = remission.

    Measured: Week 24

  2. vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24

    The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI < 2.8 = remission.

    Measured: Week 24

  3. Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24

    The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI < 3.3 = remission.

    Measured: Week 24

  4. Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24

    The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5. RADAI-5 from 0-1.4 = remission.

    Measured: Week 24

  5. Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

    HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.

    Measured: Weeks 12 and 24

  6. Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score

    SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.

    Measured: Weeks 12 and 24

  7. Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores

    VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.

    Measured: Weeks 12 and 24

  8. Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score

    TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.

    Measured: 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 posted30 Apr 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01587989
Sponsor's protocol ID
ML27837
Other IDs
2011-001863-39
Status last verified
Jun 2015
First submitted
12 Mar 2012
Last updated
17 Jul 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 13 sites in Austria.

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 6 inclusion and 15 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 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Austria. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Week 12 (Randomization) to Week 24 in DAS28 (time frame: Weeks 12 and 24). 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 NCT01587989.

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 17 Jul 2015.

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