Rheumatoid ArthritisPhase 4NCT00424502

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

A Phase 4 study testing rituximab [MabThera/Rituxan] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Hungary.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: rituximab [MabThera/Rituxan] and Methotrexate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 3 sitesHungary
Study dates: Jan 2007to Oct 2009
Phase: Phase 4
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;
diagnosed RA for >=3 months prior to first administration of study medication;
inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Who cannot join

other chronic inflammatory diseases;
use of parental corticosteroids within 4 weeks prior to screening;
severe heart failure, or severe, uncontrolled cardiac disease.

Trial locations and contacts

3 sites in 1 country.

Hungary3 sites

Study site
Budapest, 1023
Study site
Budapest, 1027
Study site
Debrecen, 4032

Other trials in Hungary

About this study

Official title: An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions: Rheumatoid Arthritis
Being tested: rituximab [MabThera/Rituxan], Methotrexate
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
Also called MabThera/Rituxan
1g iv on days 1 and 15
MethotrexateDrug
10-25mg po/week

Study groups in NCT00424502
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: rituximab [MabThera/Rituxan]; Drug: Methotrexate

What is being measured

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

Disease Activity Score Based on 28-Joint Count (DAS28)
DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.
Measured: Day 0 and Week 24

Secondary outcomes (5)

Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
Measured: Day 0 and Week 24
Anti-cyclic Citrullinated Peptide (Anti-CCP)
Anti-CCP measured as absorbance units per milliliter (AU/mL).
Measured: Day 0 and Week 24
Vascular Endothelial Growth Factor (VEGF)
VEGF was measured as picograms per milliliter (pg/mL).
Measured: Day 0 and Week 24
Erythrocyte Sedimentation Rate (ESR)
ESR was measured in mm/hr.
Measured: Day 0 and Week 24
C-Reactive Protein (CRP)
CRP was measured in milligrams per liter (mg/L).
Measured: Day 0 and Week 24

Timeline

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

Jan 2007Oct 2009

First posted19 Jan 2007 (estimated)
Study startJan 2007
Primary completionOct 2009
Study completionOct 2009

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00424502
Sponsor's protocol ID: ML20538
Status last verified: Apr 2016
First submitted: 18 Jan 2007
Last updated: 9 May 2016
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

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

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2016. 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 on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
ClinicalTrials.gov ID: NCT00424502
Acronym / sponsor ID: ML20538
Conditions: Rheumatoid Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Jan 2007 (estimated)
Results: Posted 14 Jul 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
1	Experimental	Drug: rituximab [MabThera/Rituxan], Drug: Methotrexate

Who may qualify

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

Key inclusion criteria (4 listed)

adult patients, >=18 years of age;
diagnosed RA for >=3 months prior to first administration of study medication;
inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Key exclusion criteria (3 listed)

other chronic inflammatory diseases;
use of parental corticosteroids within 4 weeks prior to screening;
severe heart failure, or severe, uncontrolled cardiac disease.

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]Also: MabThera/Rituxan1g iv on days 1 and 15	Drug	1
Methotrexate10-25mg po/week	Drug	1

Primary outcome

Disease Activity Score Based on 28-Joint Count (DAS28)
Time frame: Day 0 and Week 24
DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.

5 secondary outcomes

Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores
Time frame: Day 0 and Week 24
Anti-cyclic Citrullinated Peptide (Anti-CCP)
Time frame: Day 0 and Week 24
Vascular Endothelial Growth Factor (VEGF)
Time frame: Day 0 and Week 24
Erythrocyte Sedimentation Rate (ESR)
Time frame: Day 0 and Week 24
C-Reactive Protein (CRP)
Time frame: Day 0 and Week 24

Results and safety

Results posted to the registry on 14 Jul 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 1000 Milligrams (mg)	20	20

Primary outcome: Disease Activity Score Based on 28-Joint Count (DAS28)

Time frame: Day 0 and Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Rituximab 1000 mg n = 20
Day 0	6.03 (0.96)
Week 24	4.01 (1.49)

Rituximab 1000 mg: Mean Difference (Final Values): 2.017 (95% CI 1.39 to 2.64), p <0.0001, t-test, 2 sided

Population analysed: All enrolled participants who received at least one dose of study treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rituximab 1000 mg	0 of 20 (0%)	9 of 20 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

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 4 study testing rituximab [MabThera/Rituxan] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Hungary.

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 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: finished, as of the sponsor's last update on 9 May 2016. 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 Hungary. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Jul 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?

Disease Activity Score Based on 28-Joint Count (DAS28) (time frame: Day 0 and 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 NCT00424502.

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 9 May 2016.