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

NCT01225393 | Completed Phase 2

• 2 other identifiers: ALT4864gGA00932
• Study Type: interventional
• Target: 211
• Locations: 10 countries
• Sites: 67

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

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

  Day 85

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

  Length of study (through Day 85)

Secondary Outcomes (12)

• 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 )

  Day 85

• 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 )

  Day 85

• 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)

  Day 85

• Tender joint count

  Day 85

• Swollen joint count

  Day 85

Study Arms (3)

A

EXPERIMENTAL

Drug: MLTA3698A; Drug: leflunomide; Drug: methotrexate

B

ACTIVE COMPARATOR

Drug: adalimumab; Drug: leflunomide; Drug: methotrexate; Drug: placebo

C

PLACEBO COMPARATOR

Drug: leflunomide; Drug: methotrexate; Drug: placebo

Interventions

MLTA3698A DRUG

Subcutaneous repeating dose

A

adalimumab DRUG

Subcutaneous repeating dose

B

leflunomide DRUG

Stable dose if not on methotrexate

A; B; C

methotrexate DRUG

Stable dose if not on leflunomide

A; B; C

placebo DRUG

Subcutaneous repeating dose

B; C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (67)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Peoria, Arizona, 85381, United States

Location

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Upland, California, 91786, United States

Location

Unknown Facility

Ormond Beach, Florida, 32174, United States

Location

Unknown Facility

Lexington, Kentucky, 40515, United States

Location

Unknown Facility

Kalamazoo, Michigan, 49009, United States

Location

Unknown Facility

Flowood, Mississippi, 39232, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

Charleston, South Carolina, 29406, United States

Location

Unknown Facility

San Antonio, Texas, 78217, United States

Location

Unknown Facility

Chesapeake, Virginia, 23320, United States

Location

Unknown Facility

Clarksburg, West Virginia, 26301, United States

Location

Unknown Facility

Sofia, 1233, Bulgaria

Location

Unknown Facility

Sofia, 1407, Bulgaria

Location

Unknown Facility

Sofia, 1505, Bulgaria

Location

Unknown Facility

Santiago, 00000, Chile

Location

Unknown Facility

Santiago, 7501126, Chile

Location

Unknown Facility

Santiago, 7510186, Chile

Location

Unknown Facility

Bad Nauheim, 61231, Germany

Location

Unknown Facility

Berlin, 14059, Germany

Location

Unknown Facility

Cologne, 50924, Germany

Location

Unknown Facility

Erfurt, 99096, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Herne, 44649, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Zerbst, 39261, Germany

Location

Unknown Facility

Békéscsaba, 5600, Hungary

Location

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Budapest, 1036, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Veszprém, H-8200, Hungary

Location

Unknown Facility

Culiacán, 80000, Mexico

Location

Unknown Facility

Guadalajara, 44340, Mexico

Location

Unknown Facility

Guadalajara, 44600, Mexico

Location

Unknown Facility

Guadalajara, 44690, Mexico

Location

Unknown Facility

León, 37320, Mexico

Location

Unknown Facility

Mexicali, 21100, Mexico

Location

Unknown Facility

Mexico City, 06700, Mexico

Location

Unknown Facility

Mérida, 97000, Mexico

Location

Unknown Facility

México, 44620, Mexico

Location

Unknown Facility

Monterrey, NL, 64000, Mexico

Location

Unknown Facility

Lima, 41, Peru

Location

Unknown Facility

Lima, Lima 1, Peru

Location

Unknown Facility

Lima, Lima 25, Peru

Location

Unknown Facility

Lima, Lima 27, Peru

Location

Unknown Facility

Lima, Lima 34, Peru

Location

Unknown Facility

Lima, Lima 41, Peru

Location

Unknown Facility

San Isidro, L27 Lima, Peru

Location

Unknown Facility

San Isidro, Lima 27, Peru

Location

Unknown Facility

Bialystok, 15-099, Poland

Location

Unknown Facility

Bialystok, 15-461, Poland

Location

Unknown Facility

Elblag, 82-300, Poland

Location

Unknown Facility

Kościan, 64-000, Poland

Location

Unknown Facility

Krakow, 30-510, Poland

Location

Unknown Facility

Lublin, 20-607, Poland

Location

Unknown Facility

Warsaw, 02-653, Poland

Location

Unknown Facility

Baia Mare, 430031, Romania

Location

Unknown Facility

Bucharest, 010584, Romania

Location

Unknown Facility

Bucharest, 011172, Romania

Location

Unknown Facility

Cluj-Napoca, 400006, Romania

Location

Unknown Facility

Galati, 800578, Romania

Location

Unknown Facility

Torrelavega, Cantabria, 39300, Spain

Location

Unknown Facility

A Coruña, La Coruña, 15006, Spain

Location

Unknown Facility

Seville, Sevilla, 41071, Spain

Location

Unknown Facility

S. Cristobal de La Laguna, Tenerife, 38320, Spain

Location

Related Publications (1)

• 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.

  PMID: 25359150 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

pateclizumab; Adalimumab; Leflunomide; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John C. Davis, Jr., M.D., M.P.H.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

DE (8); HU (5); BU (3); US (14); RO (5); CL (3); PE (8); ME (10); PL (7); ES (4)