AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT00502996

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

A Phase 3 study testing Methotrexate and rituximab [MabThera/Rituxan] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 49 sites in 10 countries.

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

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. 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 rituximab [MabThera/Rituxan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
49 sitesin 10 countries
Study dates
Feb 2006to Dec 2008
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 >=6 months;
  • lack of response to 1-5 DMARDs or biological agents;
  • rheumatoid factor positive.

Who cannot join

  • other chronic inflammatory articular disease or systemic rheumatic disease;
  • joint or bone surgery during 8 weeks prior to randomization;
  • previous treatment with any cell-depleting therapy.

Trial locations and contacts

49 sites in 10 countries.

49 sites in 10 countries

Brazil26 sites

  • Study site

    Belém, 66063-240

  • Study site

    Brasília, 70322000

  • Study site

    Brasília, 70390-904

  • Study site

    Campinas, 13015-001

  • Study site

    Campinas, 13025-141

  • Study site

    Curitiba, 80730-000

  • Study site

    Florianópolis, 88040-970

  • Study site

    Fortaleza, 60155-290

  • Study site

    Fortaleza, 60430-370

  • Study site

    Goiânia, 74110010

  • Study site

    Nova Lima, 34000-000

  • Study site

    Porto Alegre, 90610-000

  • Study site

    Recife, 50000-000

  • Study site

    Ribeirão Preto, 14048-900

  • Study site

    Rio de Janeiro, 20551-030

  • Study site

    Rio de Janeiro, 21941-590

  • Study site

    Rio de Janeiro, 22050-000

  • Study site

    Rio de Janeiro, 22640102

  • Study site

    Salvador, 40050-410

  • Study site

    São Paulo, 03128-050

  • Study site

    São Paulo, 04026-000

  • Study site

    São Paulo, 04038-002

  • Study site

    São Paulo, 04038-040

  • Study site

    São Paulo, 04039-004

  • Study site

    São Paulo, 05403-000

  • Study site

    Vitória, 29043-910

Other trials in Brazil

Argentina5 sites

  • Study site

    Buenos Aires, 1425

  • Study site

    Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, C1426AAL

  • Study site

    Córdoba, 5000

  • Study site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Mexico4 sites

  • Study site

    Mexico City, 02990

  • Study site

    Mexico City, 06920

  • Study site

    Mexico City, 14080

  • Study site

    San Luis Potosí City, 78240

Other trials in Mexico

Ecuador3 sites

  • Study site

    Cuenca, 1394

  • Study site

    Guayaquil

  • Study site

    Quito, 1394

Other trials in Ecuador

Peru3 sites

  • Study site

    Jesus Maria

  • Study site

    Lima, 13

  • Study site

    San Isidro, LIMA 27

Other trials in Peru

Venezuela3 sites

  • Study site

    Barquisimeto, 3005

  • Study site

    Caracas, 1010

  • Study site

    Caracas, 1040

Other trials in Venezuela

Colombia2 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

Other trials in Colombia

Chile1 site

  • Study site

    Santiago

Other trials in Chile

El Salvador1 site

  • Study site

    San Salvador

Other trials in El Salvador

Uruguay1 site

  • Study site

    Montevideo, 11600

Other trials in Uruguay

About this study

Official title: Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Being tested
Methotrexate, rituximab [MabThera/Rituxan]
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 mg po/week

  • rituximab [MabThera/Rituxan]Drug

    1g iv on days 1 and 15

Study groups in NCT00502996
Study groupRoleWhat they receive
RituximabExperimentalEligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
Receives: Drug: Methotrexate; Drug: rituximab [MabThera/Rituxan]

What is being measured

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

  1. Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death

    An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.

    Measured: Up to Week 48

  2. Number of Participants With AEs According to Degree of Intensity

    An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).

    Measured: Up to Week 48

  3. Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs

    An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification "Yes" and "No". A relationship classified as "Yes" implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments.

    Measured: Up to Week 48

  4. Number of Participants With AEs of Special Interest During the Study

    Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.

    Measured: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)

Secondary outcomes (17)

  1. Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)

    The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  2. Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)

    The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  3. Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)

    Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  4. Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)

    The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  5. Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)

    The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  6. Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)

    The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  7. Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.

    The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  8. Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit

    The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  9. Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit

    The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.

    Measured: Screening (Days -28 to 0) and EOT (Week 24)

  10. Mean Duration of Morning Joint Stiffness

    The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.

    Measured: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)

  11. Mean Value of Painful Joints

    The efficacy of rituximab was assessed by evaluating painful joints.

    Measured: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)

  12. Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria

    American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient's assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient's global assessment of disease activity and physician's global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.

    Measured: Week 1, Week 12, and Week 24

  13. Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)

    Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant's activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).

    Measured: Screening (Days -28 to 0), Week 1, Week 12, and Week 24

  14. Mean Values of C Reactive Protein

    C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.

    Measured: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)

  15. Mean Values of Globular Sedimentation Velocity

    Globular sedimentation velocity is a component of ACR.

    Measured: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24

  16. Mean Values of Pain and Activity Based on Visual Analogue Scale

    Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).

    Measured: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24

  17. Mean Value of Inflamed Joints

    The efficacy of rituximab was assessed by evaluating inflamed joints.

    Measured: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)

Timeline

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

  1. First posted18 Jul 2007 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00502996
Sponsor's protocol ID
ML19385
Status last verified
Aug 2016
First submitted
17 Jul 2007
Last updated
14 Oct 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and rituximab [MabThera/Rituxan] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 49 sites in 10 countries.

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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Brazil, Argentina, Mexico, Ecuador, Peru and 5 more countries. 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 14 Oct 2016). 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?

Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death (time frame: Up to Week 48). The study lists 4 primary outcomes in all. 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 NCT00502996.

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 14 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in