NCT01023256

Brief Summary

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Dec 2009

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

November 19, 2009

Results QC Date

April 7, 2014

Last Update Submit

October 15, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisGM-CSFMOR103

Outcome Measures

Primary Outcomes (1)

  • Percentages of Patients With Treatment-emergent or Serious Adverse Events

    Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of \>5 % (\>1 patient) in any treatment group, please see the adverse events listing.

    From the first dose through the 16-week visit

Secondary Outcomes (5)

  • Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks

    Change from baseline to week 4 (1 week after last MOR103 dose)

  • Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks

    Change from baseline to week 8 (5 weeks after last MOR103 dose)

  • Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4

    Week 4 (1 week after last MOR103 dose)

  • Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8

    Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8

  • Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8

    Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8

Other Outcomes (2)

  • Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4

    Change from screening to week 4 (1 week after last MOR103 dose)

  • Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8

    Change from screening to week 8

Study Arms (3)

Group 1: MOR103, experimental

EXPERIMENTAL

Biological: MOR103 0.3 mg/kg or placebo

Drug: MOR103

Group 2: MOR103, experimental

EXPERIMENTAL

Biological: MOR103 1.0 mg/kg or placebo

Drug: MOR103

Group 3: MOR103, experimental

EXPERIMENTAL

Biological: MOR103 1.5 mg/kg or placebo

Drug: MOR103

Interventions

MOR103DRUG

MOR103 0.3 mg/kg or placebo iv x 4 doses

Group 1: MOR103, experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis (RA) per revised 1987 ACR criteria
  • Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
  • CRP \> 5.0 mg/L (RF and anti-CCP seronegative); CRP \>2 mg/l (RF and/or anti-CCP seropositive)
  • DAS28 ≤ 5.1
  • Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
  • Negative PPD tuberculin skin test

You may not qualify if:

  • Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
  • Any history of ongoing, significant or recurring infections
  • Any active inflammatory diseases other than RA
  • Treatment with a systemic investigational drug within 6 months prior to screening
  • Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
  • Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
  • Hepatic or renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MorphoSys Investigative sites

MorphoSys Investigative Sites, Bulgaria

Location

MorphoSys Investigative sites

MorphoSys Investigative Sites, Germany

Location

MorphoSys Investigative sites

MorphoSys Investigative Sites, Netherlands

Location

MorphoSys Investigative sites

MorphoSys Investigative Sites, Poland

Location

MorphoSys Investigative sites

MorphoSys Investigatíve Sites, Ukraine

Location

Related Publications (1)

  • Behrens F, Tak PP, Ostergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial. Ann Rheum Dis. 2015 Jun;74(6):1058-64. doi: 10.1136/annrheumdis-2013-204816. Epub 2014 Feb 17.

    PMID: 24534756RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Otilimab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Key limitations of this trial include its small sample size, limited duration, and exclusion of patients with severe rheumatoid arthritis. Larger clinical trials are needed to confirm these data and define the optimal MOR103 dosage.

Results Point of Contact

Title
Roman Korolkiewicz
Organization
MorphoSys
Roman.Korolkiewicz@morphosys.com
+498989927

Study Officials

  • Roman P Korolkiewicz, MD, PhD

    MorphoSys AG

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

December 2, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 24, 2014

Results First Posted

May 8, 2014

Record last verified: 2014-10

Locations

PL(1)BU(1)NL(1)UA(1)DE(1)