Rheumatoid ArthritisPhase 3NCT02006706

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

A Phase 3 study testing rituximab [MabThera/Rituxan], methotrexate and methylprednisolone in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Serbia.

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 study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: rituximab [MabThera/Rituxan], methotrexate and methylprednisolone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 3 sitesSerbia
Study dates: 10 Aug 2006to 23 Nov 2007
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients, 18-80 years of age;
rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
active disease;
DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Who cannot join

autoimmune disease other than rheumatoid arthritis;
bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
concurrent treatment with any DMARD or antiTNF-alfa;
intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Trial locations and contacts

3 sites in 1 country.

Serbia3 sites

Study site
Belgrade, 11000
Study site
Niška Banja, 18250
Study site
Nova Sad, 21000

Other trials in Serbia

About this study

Official title: An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

Conditions: Rheumatoid Arthritis
Being tested: rituximab [MabThera/Rituxan], methotrexate, methylprednisolone
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

rituximab [MabThera/Rituxan]Drug
1000 mg iv Days 1 and 15
methotrexateDrug
10 - 25 mg/week
methylprednisoloneDrug
iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Study groups in NCT02006706
Study group	Role	What they receive
MabThera/Rituxan	Experimental	Not described Receives: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate; Drug: methylprednisolone

What is being measured

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

Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Measured: Baseline, Week 24

Secondary outcomes (1)

Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Measured: Baseline, Week 24

Timeline

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

10 Aug 200623 Nov 2007

First posted10 Dec 2013 (estimated)
Study start10 Aug 2006
Primary completion23 Nov 2007
Study completion23 Nov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02006706
Sponsor's protocol ID: ML20388
Status last verified: Jul 2017
First submitted: 5 Dec 2013
Last updated: 21 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure
ClinicalTrials.gov ID: NCT02006706
Acronym / sponsor ID: ML20388
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 10 Aug 2006 (actual)
Primary completion: 23 Nov 2007 (actual)
Study completion: 23 Nov 2007 (actual)
First posted: 10 Dec 2013 (estimated)
Results: Posted 6 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MabThera/Rituxan	Experimental	Drug: rituximab [MabThera/Rituxan], Drug: methotrexate, Drug: methylprednisolone

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adult patients, 18-80 years of age;
rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
active disease;
DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Key exclusion criteria (4 listed)

autoimmune disease other than rheumatoid arthritis;
bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
concurrent treatment with any DMARD or antiTNF-alfa;
intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

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
rituximab [MabThera/Rituxan]1000 mg iv Days 1 and 15	Drug	MabThera/Rituxan
methotrexate10 - 25 mg/week	Drug	MabThera/Rituxan
methylprednisoloneiv administration on Day 1 and 15 prior to MabThera/Rituxan infusion	Drug	MabThera/Rituxan

Primary outcome

Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
Time frame: Baseline, Week 24
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.

1 secondary outcome

Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 6 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rituximab/Methylprednisolone/Methotrexate (MTX)	15	14

Primary outcome: Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Rituximab/Methylprednisolone/MTX n = 14
Value	2.98 (1.80)

Rituximab/Methylprednisolone/MTX: Mean Difference (Final Values): 2.98 (95% CI 1.73 to 4.22), p <0.001, t-test, 2 sided

Population analysed: Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were reported starting with the first dose of study drug through the end of the study (24 weeks total).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rituximab/Methylprednisolone/MTX	2 of 14 (14.3%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 1
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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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.

Clinical Trials study director

Hoffmann-La Roche

3 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 rituximab [MabThera/Rituxan], methotrexate and methylprednisolone in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Serbia.

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 4 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Serbia. 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 6 Nov 2014). 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 Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 (time frame: Baseline, Week 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 NCT02006706.

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 21 Aug 2017.