AzTrials
AzTrials

Rheumatoid ArthritisPhase 2NCT01225393

A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

A Phase 2 study testing MLTA3698A, adalimumab and leflunomide in people with Rheumatoid Arthritis, run by Genentech, Inc. at 67 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 is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
MLTA3698A, adalimumab and leflunomide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
67 sitesin 10 countries
Study dates
Nov 2010to Jul 2012
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
  • Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
  • Active disease, defined as: CRP >= 1.0 mg/dL; swollen joint count >= 6 (66 joint count); tender joint count >= 6 (68 joint count)
  • Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
  • For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
  • For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
  • For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
  • For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines

Who cannot join

  • Pregnant, planning to become pregnant during the study, or breastfeeding
  • Clinically significant abnormal laboratory values or abnormal ECG or vital signs
  • History of anaphylactic reactions
  • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
  • History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
  • Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
  • Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
  • Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)

Trial locations and contacts

67 sites in 10 countries.

67 sites in 10 countries

United States14 sites

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Clarksburg, West Virginia, 26301

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Lexington, Kentucky, 40515

  • Study site

    Los Angeles, California, 90033

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Reno, Nevada, 89502

  • Study site

    San Antonio, Texas, 78217

  • Study site

    Upland, California, 91786

Other trials in United States

Mexico10 sites

  • Study site

    Culiacán, 80000

  • Study site

    Guadalajara, 44340

  • Study site

    Guadalajara, 44600

  • Study site

    Guadalajara, 44690

  • Study site

    León, 37320

  • Study site

    Mérida, 97000

  • Study site

    Mexicali, 21100

  • Study site

    México, 44620

  • Study site

    Mexico City, 06700

  • Study site

    Monterrey, NL, 64000

Other trials in Mexico

Germany8 sites

  • Study site

    Bad Nauheim, 61231

  • Study site

    Berlin, 14059

  • Study site

    Cologne, 50924

  • Study site

    Erfurt, 99096

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Herne, 44649

  • Study site

    Kiel, 24105

  • Study site

    Zerbst, 39261

Other trials in Germany

Peru8 sites

  • Study site

    Lima, 41

  • Study site

    Lima, Lima 1

  • Study site

    Lima, Lima 25

  • Study site

    Lima, Lima 27

  • Study site

    Lima, Lima 34

  • Study site

    Lima, Lima 41

  • Study site

    San Isidro, L27 Lima

  • Study site

    San Isidro, Lima 27

Other trials in Peru

Poland7 sites

  • Study site

    Bialystok, 15-099

  • Study site

    Bialystok, 15-461

  • Study site

    Elblag, 82-300

  • Study site

    Kościan, 64-000

  • Study site

    Krakow, 30-510

  • Study site

    Lublin, 20-607

  • Study site

    Warsaw, 02-653

Other trials in Poland

Hungary5 sites

  • Study site

    Békéscsaba, 5600

  • Study site

    Budapest, 1027

  • Study site

    Budapest, 1036

  • Study site

    Debrecen, 4032

  • Study site

    Veszprém, H-8200

Other trials in Hungary

Romania5 sites

  • Study site

    Baia Mare, 430031

  • Study site

    Bucharest, 010584

  • Study site

    Bucharest, 011172

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Galati, 800578

Other trials in Romania

Spain4 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    S. Cristobal de La Laguna, Tenerife, 38320

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Torrelavega, Cantabria, 39300

Other trials in Spain

Bulgaria3 sites

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1505

Other trials in Bulgaria

Chile3 sites

  • Study site

    Santiago, 00000

  • Study site

    Santiago, 7501126

  • Study site

    Santiago, 7510186

Other trials in Chile

About this study

Official title: A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis

This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).

Being tested
MLTA3698A, adalimumab, leflunomide, methotrexate, placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • MLTA3698ADrug

    Subcutaneous repeating dose

  • adalimumabDrug

    Subcutaneous repeating dose

  • leflunomideDrug

    Stable dose if not on methotrexate

  • methotrexateDrug

    Stable dose if not on leflunomide

  • placeboDrug

    Subcutaneous repeating dose

Study groups in NCT01225393
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: MLTA3698A; Drug: leflunomide; Drug: methotrexate
BActive comparatorNot described
Receives: Drug: adalimumab; Drug: leflunomide; Drug: methotrexate; Drug: placebo
CPlacebo comparatorNot described
Receives: Drug: leflunomide; Drug: methotrexate; Drug: placebo

What is being measured

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

  1. Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR

    Measured: Day 85

  2. Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A

    Measured: Length of study (through Day 85)

Secondary outcomes (12)

  1. ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )

    Measured: Day 85

  2. ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )

    Measured: Day 85

  3. ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)

    Measured: Day 85

  4. Tender joint count

    Measured: Day 85

  5. Swollen joint count

    Measured: Day 85

  6. Investigator Global Assessment of Disease Activity

    Measured: Day 85

  7. Patient Global Assessment of Pain and Disease Activity

    Measured: Day 85

  8. Health Assessment Questionnaire Disability Index

    Measured: Day 85

  9. Patient's Global Health or Short Form Health Survey (SF-36)

    Measured: Day 85

  10. European League Against Rheumatism response rate

    Measured: Day 85

  11. Serum C-reactive protein levels

    Measured: Day 85

  12. Erythrocyte sedimentation rate

    Measured: Day 85

Timeline

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

  1. First posted21 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2012

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
Double blind
Who is masked
Participant, Investigator
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01225393
Sponsor's protocol ID
ALT4864g
Other IDs
GA00932
Status last verified
Nov 2016
First submitted
18 Oct 2010
Last updated
2 Nov 2016
Results posted
No

Publications

  • Kennedy WP, Simon JA, Offutt C, Horn P, Herman A, Townsend MJ, Tang MT, Grogan JL, Hsieh F, Davis JC. Efficacy and safety of pateclizumab (anti-lymphotoxin-alpha) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study). Arthritis Res Ther. 2014 Oct 30;16(5):467. doi: 10.1186/s13075-014-0467-3.

    PubMed 25359150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MLTA3698A, adalimumab and leflunomide in people with Rheumatoid Arthritis, run by Genentech, Inc. at 67 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 8 inclusion and 8 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 2 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 67 sites in United States, Mexico, Germany, Peru, Poland 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. Some participants in this study may receive a placebo. 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?

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (time frame: Day 85). The study lists 2 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 NCT01225393, which also lists 1 linked publication.

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 2 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