AzTrials
AzTrials

Rheumatoid ArthritisPhase 2NCT02693210

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

A Phase 2 study testing Cyclophosphamide and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 33 sites in 11 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

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Cyclophosphamide and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
33 sitesin 11 countries
Study dates
Feb 2001to Aug 2004
Phase
Phase 2
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with moderate to severe rheumatoid arthritis (RA) who have previously failed 1-5 DMARDS who currently have partial clinical response to treatment with methotrexate
  • Using methotrexate as a single DMARD for at least 16 weeks, of which the last 4 weeks prior to baseline on a stable oral dose greater than or equal to (>=) 10 milligrams per week (mg/week)
  • >=21 years of age
  • Swollen Joint Count (SJC) and Tender Joint Count (TJC) >= 8 (out of 66 and 68 joints respectively)
  • At least 2 of the following parameters at Baseline: C- Reactive Protein >= 15 mg/dL; Erythrocyte Sedimentation Rate >= 30 millimeters per hour (mm/hr); Morning stiffness >45 minutes
  • Rheumatoid factor titer >=20 International units per milliliter (IU/mL)
  • Corticosteroid (less than or equal to [=<] 12.5 milligrams per deciliter [mg/d] prednisone or equivalent) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are permitted if stable for at least 4 weeks prior to baseline

Who cannot join

  • American Rheumatism Association (ARA) Class IV RA disease
  • Concurrent treatment with any DMARD (apart from randomized treatment) or anti-TNF-alpha therapy
  • Active infection or history of recurrent significant infection
  • Prior history of cancer including solid tumors and hematologic malignancies (except basal carcinoma of the skin that have been excised and cured)
  • Evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
  • Bone/joint surgery within 6 weeks prior to screening
Show all 10Show fewer
  • Rheumatic Autoimmune disease other than RA
  • Active rheumatoid vasculitis
  • Prior history of gout
  • Chronic fatigue syndrome

Trial locations and contacts

33 sites in 11 countries.

33 sites in 11 countries

Spain5 sites

  • Study site

    Guadalajara, 19002

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28046

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Seville, 41014

Other trials in Spain

Italy4 sites

  • Study site

    Brescia, 25123

  • Study site

    Genova, 16132

  • Study site

    Modena, 41100

  • Study site

    Siena, 53100

Other trials in Italy

Poland4 sites

  • Study site

    Lublin, 20-022

  • Study site

    Poznan, 61-545

  • Study site

    Warsaw, 02-637

  • Study site

    Wroclaw, 50-556

Other trials in Poland

United Kingdom4 sites

  • Study site

    Cannock, WS11 5XY

  • Study site

    Leeds, LS1 3EX

  • Study site

    London, W1P 9PG

  • Study site

    Stoke-on-Trent, ST6 7AG

Other trials in United Kingdom

Australia3 sites

  • Study site

    Darlinghurst, 2010

  • Study site

    Kogarah, 2217

  • Study site

    Woodville, 5011

Other trials in Australia

Belgium3 sites

  • Study site

    Diepenbeek, 3590

  • Study site

    Ghent, 9000

  • Study site

    Liège, 4000

Other trials in Belgium

Canada3 sites

  • Study site

    Montreal, Quebec, H2L 1S6

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

Germany3 sites

  • Study site

    Leipzig, 04107

  • Study site

    Ratingen, 40882

  • Study site

    Wiesbaden, 65191

Other trials in Germany

Israel2 sites

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 34354

Other trials in Israel

Czechia1 site

  • Study site

    Prague, 128 50

Other trials in Czechia

Netherlands1 site

  • Study site

    Leiden, 2333 ZA

Other trials in Netherlands

About this study

Official title: A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.

Being tested
Cyclophosphamide, Methotrexate, Placebo Cyclophosphamide, Placebo Methotrexate, Placebo Rituximab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • CyclophosphamideDrug

    Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17

  • MethotrexateDrug

    Participants will receive >= 10 mg/week methotrexate orally up to 24 weeks

  • Placebo CyclophosphamideOther

    Participants will receive placebo in place of cyclophosphamide on Days 3 and 17

  • Placebo MethotrexateOther

    Participants will receive weekly oral placebo in place of Methotrexate

  • Placebo RituximabOther

    Participants will receive placebo in place of rituximab on days 1 and 15

  • RituximabDrug

    Participants will receive 1g infusions of rituximab on Days 1 and 15

Study groups in NCT02693210
Study groupRoleWhat they receive
Group A: MethotrexateActive comparatorParticipants will receive methotrexate at dosage >=10 milligrams per week (mg/week) orally as determined by the investigator. They also receive placebo infusion on days 1 and 15 in place of rituximab and on Days 3 and 17 in place of cyclophosphamide.
Receives: Drug: Methotrexate; Other: Placebo Cyclophosphamide; Other: Placebo Rituximab
Group B: Rituximab MonotherapyExperimentalParticipants will receive 1 g intravenous infusions of rituximab on Days 1 and 15. They also receive Weekly placebo orally instead of methotrexate and placebo infusion in place of cyclophosphamide on Days 3 and 17.
Receives: Other: Placebo Cyclophosphamide; Other: Placebo Methotrexate; Drug: Rituximab
Group C: Rituximab and CyclophosphamideExperimentalParticipants will receive 1g IV infusion of rituximab on Days 1 and 15 and 750 mg infusion of Cyclophosphamide on Days 3 and 17. They also receive weekly oral placebo in place of methotrexate.
Receives: Drug: Cyclophosphamide; Other: Placebo Methotrexate; Drug: Rituximab
Group D: Methotrexate and RituximabExperimentalParticipants will receive >=10 mg/week methotrexate orally along with 2 times 1 gram (g) rituximab IV infusions on Days 1 and 15. Participants will also receive placebo infusions on Days 3 and 17 in place of cyclophosphamide.
Receives: Drug: Methotrexate; Other: Placebo Cyclophosphamide; Drug: Rituximab

What is being measured

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

  1. Percentage of participants achieving American College of Rheumatology (ACR) 50 response at Week 24

    Measured: Week 24

Secondary outcomes (13)

  1. Percentage of participants achieving ACR 20 and ACR 70 responses at Week 24

    Measured: Week 24

  2. Area Under the Curve (AUC) of American College of Rheumatology Response (ACRn)

    Measured: Baseline up to Week 24

  3. AUC of the mean Disease Activity Scores (DAS)

    Measured: Baseline up to Week 24

  4. Change from Baseline in the Swollen Joint Count

    Measured: Baseline, Weeks 12, 16, 20 and 24

  5. Change from Baseline in the Tender Joint Count

    Measured: Baseline, Weeks 12, 16, 20 and 24

  6. Change from Baseline in participant's global assessment of disease activity using a Visual Analog Scale (VAS)

    Measured: Baseline, Weeks 8, 12, 16, 20 and 24

  7. Change from Baseline in physician's global assessment of disease activity using VAS

    Measured: Baseline, Weeks 8, 12, 16, 20 and 24

  8. Change from Baseline in the Health Assessment Questionnaire - Disease Index (HAQ-DI) scores

    Measured: Baseline, Weeks 12, 16, 20 and 24

  9. Change from Baseline in participant's pain measured by VAS

    Measured: Baseline, Weeks 12, 16, 20 and 24

  10. Change from Baseline in C-Reactive Protein (CRP) Levels

    Measured: Baseline, Weeks 12, 16, 20 and 24

  11. Change from Baseline in Erythrocyte Sedimentation Rate (ESR)

    Measured: Baseline, Weeks 12, 16, 20 and 24

  12. Mean change in Rheumatoid factor levels at 24 weeks

    Measured: Baseline and Week 24

  13. Percentage of participants who withdrew due to insufficient therapeutic response

    Measured: Up to 24 Weeks

Timeline

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

  1. First posted26 Feb 2016 (estimated)
  2. Study startFeb 2001
  3. Primary completionAug 2002
  4. Study completionAug 2004

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02693210
Sponsor's protocol ID
WA16291
Status last verified
Oct 2016
First submitted
23 Feb 2016
Last updated
1 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 33 sites in 11 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 7 inclusion and 10 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Spain, Italy, Poland, United Kingdom, Australia and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percentage of participants achieving American College of Rheumatology (ACR) 50 response at Week 24 (time frame: 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 NCT02693210.

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 1 Nov 2016.

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